Cardiac treatment system and method

ABSTRACT

Devices and methods for providing localized pressure to a region of a patient&#39;s heart to improve heart functioning, including: (a) a jacket made of a flexible biocompatible material, the jacket having an open top end that is received around the heart and a bottom portion that is received around the apex of the heart; and (b) at least one inflatable bladder disposed on an interior surface of the jacket, the inflatable bladder having an inelastic outer surface positioned adjacent to the jacket and an elastic inner surface such that inflation of the bladder causes the bladder to deform substantially inwardly to exert localized pressure against a region of the heart.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This application is a continuation of U.S. patent application Ser. No.15/162,029 filed on May 23, 2016, which is a continuation of U.S. patentapplication Ser. No. 14/053,590 filed Oct. 14, 2013, which claimspriority to U.S. Provisional Patent Application No. 61/713,351 filed onOct. 12, 2012 by Hjelle et al., the contents of which are fullyincorporated herein by reference.

TECHNICAL FIELD

The present disclosure relates to medical devices for treating heartdiseases and valvular dysfunction, including valvular regurgitation.

BACKGROUND OF THE INVENTION

Various compression-style systems currently exist for treating heartdiseases and conditions such as congestive heart disease and valvulardysfunction. These systems typically involve either: (a) jackets thatare placed around the heart to limit heart expansion to treat congestiveheart disease, or (b) bands that are placed around the heart withfillable chambers to exert localized pressure to re-form the shape ofheart valves, for example to minimize valve leakage.

An example of the former is found in U.S. Published Patent Application2010/0160721 entitled “Cardiac Support Device With DifferentialCompliance.” This device is used to treat congestive heart disease.Congestive heart disease is the progressive enlargement of the heart.This enlargement requires the heart to perform an increasing amount ofwork. In time, the heart cannot supply an adequate amount of blood,resulting in a patient that is fatigued and in discomfort. The cardiacsupport device of U.S. Application 2101/0160721 limits heart expansionusing a flexible jacket positioned around the heart. An example of thesecond type of system is found in Mardil, Inc.'s U.S. Pat. No. 8,092,363entitled “Heart Band With Fillable Chambers To Modify Heart ValveFunction.” This device has fillable chambers that exert inward radialforces on heart valves. The fillable chambers are disposed within innerand outer layers of a silicone rubber band.

SUMMARY

Some embodiments described herein provide a system including an cardiacimplant structure configured to be positioned around the exterior of anepicardial surface of a heart. Such a system can be used, for example,to treat various heart conditions, including but not limited tofunctional mitral regurgitation (“FMR”), tricuspid valve regurgitation,congestive heart failure, or a combination thereof. The implantstructure can include a mesh body having a leading hem region configuredto elastically flex and engage with an atrial-ventricular groove of theheart, and a fillable bladder mounted to the mesh body at apredetermined location so as to provide localized pressure at a targetedsurface region of the heart spaced apart from the atrial-ventriculargroove. The implant structure can be equipped with radiopaque markers atselected locations along the leading hem region, along or within thefillable bladder, or a combination thereof, so that the relativepositioning of the implant structure and the targeted landmarks of theheart can be readily identified both during and after an implantationprocedure. For example, in particular embodiments, the fillable bladder(equipped with markers along a periphery thereof) can be coupled to themesh body at a specific location to exert a localized pressure on theposterior lateral surface of the heart to thereby deflect the “P2”portion of the posterior leaflet of the mitral valve to treat FMR.Accordingly, the combined components of the implant structure can beconfigured to apply supporting or deformation forces to multipletargeted regions of the heart in a manner that supports the ventriclewalls of the heart, particular valve structures of the heart, and(optionally) the atrial-ventricular groove of the heart.

Additionally, some embodiments of a method for delivering the implantstructure to the heart can be achieved in a minimally invasive mannerthat benefits both the clinician and the user. A delivery device can beoperated by a surgeon or other clinician to advance the implantstructure through a relatively small opening of a selected intercostalspace before the implant structure expands over the apex, ventricles,and atrial-ventricular groove of the heart. In a particular embodiment,the implant structure can be pre-loaded on the delivery device andpackaged in a sterilized kit so that the clinician can advantageouslybegin the implantation procedure without first having to load theimplant device onto the delivery device. Also, the implant structure mayoptionally be loaded onto the delivery device in a predeterminedrelative position so that the fillable bladder has a predeterminedorientation relative to a handle of the delivery device, therebyassisting the clinician in aligning the fillable bladder with thetargeted surface region of the heart (e.g., along a posterior lateralsurface of the heart in particular implementations). In someimplementations of the method, the fillable bladder (when inflated) ofthe implant structure can be configured to expand inwardly toward theepicardial surface more so than it expands outwardly away from theheart.

Particular embodiments described herein include a cardiac implantincluding an implant body and a fillable bladder. The implant body cancomprise a mesh material, and the implant body may include a leading endportion defining an open leading end and a trailing end portion definingan open trailing end of a diameter that is less than a diameter of theopen leading end. The fillable bladder can be coupled to the implantbody. Optionally, the cardiac implant may include one or more additionalfeatures described in more detail below.

Particular embodiments described herein include a cardiac implant forimplantation around an exterior of a heart. The implant may include animplant body comprising a mesh material, which optionally is formed intoa generally tubular configuration. The implant body may also include aleading end portion defining an open leading end and a trailing endportion defining an open trailing end of a diameter that is less than adiameter of the open leading end. The trailing end portion may have alength configured to extend proximal of the apex of the heart when theleading end portion is positioned in an atrial-ventricular groove of theheart. Further, the cardiac implant may optionally include a fillablebladder mounted to the implant body. The fillable bladder may bepositioned relative to the open leading end such that, when the leadingend portion is positioned in the atrial-ventricular groove, the fillablebladder is positionable on an exterior of a heart wall. Optionally, thecardiac implant may include one or more additional features described indetail herein.

In some embodiments, a cardiac implant for implantation around anexterior of a heart may include an implant body. The implant body cancomprises a mesh material that, optionally, is formed into a generallytubular configuration. The implant body may define an open leading endand an open trailing end of a lateral width that is less than a lateralwidth of the open leading end. The implant body may include: a generallycylindrical leading end portion, a transition portion, and a generallycylindrical trailing end portion. The generally cylindrical leading endportion can define the open leading end of the implant body, and theleading end portion may have a lateral width and construction forpositioning around an atrial-ventricular groove of the heart. Thetransition portion may extend proximally from the leading end portionand may be configured to circumferentially encompass ventricles of theheart. Optionally, the transition portion can have a greater diameter atits distal end than at its proximal end. The generally cylindricaltrailing end portion may extend proximally from the transition portionand may have a length sized such that the trailing end portion extendsproximal of the apex of the heart when the leading end portion ispositioned around the atrial-ventricular groove. The cardiac implant mayalso include a fillable bladder coupled to the implant body. Thefillable bladder can be positioned such that, when the leading endportion is positioned around the atrial-ventricular groove, the fillablebladder is positionable on an exterior of a heart wall adjacent to aheart valve structure. Optionally, the cardiac implant may furtherinclude one or more additional features described in detail herein.

In particular embodiments, a cardiac implant for implantation around anexterior of a heart can include an implant body comprising a jacket ofmesh material configured for implantation circumferentially aroundventricles of the heart. The jacket may an open leading end sized forpositioning around an atrial-ventricular groove of the heart. Theimplant body may also include a hem located around a perimeter of theopen leading end. The hem may be formed from a portion of the meshmaterial and an elastic band surrounded by the portion of the meshmaterial. Optionally, the circumferential length of the elastic band maybe less than the circumferential length of the portion of the meshmaterial surrounding the elastic band. The elastic band and the portionof the mesh material surrounding the elastic band can have compliancesselected such that the hem holds the hem of the implant body in place inthe atrial-ventricular groove without interfering with cardiac bloodvessel function in the region of the atrial-ventricular groove. Also,the cardiac implant may optionally include a fillable bladder attachedon an inside of the mesh jacket. The fillable bladder may be positionedsuch that, when the implant is implanted with the hem positioned aroundthe atrial-ventricular groove, the fillable bladder is positionable onan external heart wall adjacent to a targeted heart valve structure. Thefillable bladder may include an inner layer and an opposing outer layer.The inner layer, when the hem positioned around the atrial-ventriculargroove, can be adjacent to the external heart wall. The opposing outerlayer may be adjacent to the mesh jacket. The inner layer of thefillable bladder can have a compliance that is greater than a complianceof the outer layer such that, when the bladder is inflated, the innerlayer of the bladder extends more inwardly than the outer wall extendsoutwardly. Optionally, the cardiac implant may include one or moreadditional features described in detail herein.

Some embodiments described herein include a cardiac implant forimplantation around an exterior of a heart. The cardiac implant mayinclude a mesh jacket positionable circumferentially around an exteriorthe heart. Also, the cardiac implant may include a fillable bladdermounted to the mesh jacket. The fillable bladder can include an innerbladder layer and outer bladder layer. The inner bladder layer can bepositioned with respect to the mesh jacket so that the inner bladderlayer is adjacent to a targeted exterior surface of the heat when themesh jacket is positioned around the exterior of the heart. The outerbladder layer can be positioned opposite from the inner bladder layer.Optionally, the inner bladder layer may have a compliance that isgreater than a compliance of the outer bladder layer such that, when themesh jacket is positioned around the exterior of the heart, the bladderexpands more inwardly toward the targeted exterior surface of the heartthan the bladder expands outwardly from the heart. Further, the cardiacimplant may optionally include one or more additional features describedin detail herein.

Further embodiments described herein include a cardiac implant system.The system may include a cardiac implant configured to be implantedaround an exterior of the heart. The cardiac implant can include animplant body, an inflatable bladder attached to the implant body, andflexible tubing in fluid communication with an internal chamber of theinflatable bladder for inflating and deflating the inflatable bladder.The system may optionally include biocompatible ligation clipsconfigured to attach to a proximal portion of the flexible tubing so asto seal an internal lumen of the flexible tubing. In some aspects, theligation clips are configured to reside in an intercostal space whilemaintaining a selected inflation state of the inflatable bladder.Optionally, the cardiac implant system may include one or moreadditional features described in detail herein.

In various embodiments, a cardiac implant can include a mesh jacket, afillable bladder, and one or more radiopaque markers. The mesh jacketmay be configured to circumferentially extend around an exterior portionof the heart. The fillable bladder can be attached on an interior sideof the mesh jacket. The fillable bladder may be positioned relative to aleading end of the mesh jacket such that, when the mesh jacketcircumferentially extends around the exterior portion of the heart, thefillable bladder is positionable against an external heart wall adjacentto the a targeted valve structure. The fillable bladder may include aninner layer configured to engage with the external heart wall, and anouter layer positioned between the inner layer and the mesh jacket. Theone or more radiopaque markers can be attached to an exterior side ofthe mesh jacket at a location wherein the fillable bladder is on anopposite side of the mesh jacket from the one or more radiopaquemarkers. Optionally, the cardiac implant may include one or moreadditional features described in detail herein.

Other embodiments described herein include a delivery system fordelivering an implantable cardiac device. The delivery system mayinclude an elongate barrel, a plurality of elongate members, a controlmechanism, and a handle assembly. The plurality of elongate members maybe configured to extend along a length of the elongate barrel and extenddistally from the elongate barrel. Also, the plurality of elongatemembers may be advanceable distally with respect to the elongate barrel.Each of the elongate members can include a distal end for attachment toa cardiac implant configured to be implanted around an exterior of aheart. The control mechanism can be configured to extend and retract theplurality of elongate members relative to the elongate barrel. Thehandle assembly may optionally include a pistol grip configured to beheld by a first hand of an operator while the operator uses a secondhand to operate the control mechanism for the extension and retractionof the plurality of elongate members. Optionally, the delivery systemmay include one or more additional features described in detail herein.

Some embodiments described herein include a cardiac treatment systemincluding a delivery system and a cardiac implant releasably mountedonto the delivery system. The delivery system may include an implantdelivery mechanism comprising a plurality of distally extending elongatemembers each having a distal end portion configured for attachment tothe cardiac implant. Also, the delivery system may include a proximalhandle assembly. The proximal handle assembly can include a pistol gripconfigured to be held by one hand of an operator during a procedure toimplant the cardiac implant. The pistol grip can extend in a firstradial position from a longitudinal axis of the delivery system. Thecardiac implant may include an implant body configured for implantationaround external portions of a heart. The implant body can include aleading end portion defining an open leading end and being configured toadvance over an apex of the heart. The leading end portion may bedetachably attached to the distal end portions of the elongate members.The cardiac implant may also include a fillable bladder attached to theimplant body. In particular implementations, the implant body may bemounted onto the delivery device in a second radial position from thelongitudinal axis such that an orientation of the fillable bladderrelative to the first radial position of the pistol grip of the handlealigns the fillable bladder with a targeted exterior portion of theheart (when the pistol grip of the handle is held by the one hand of theoperator during the procedure to implant the cardiac implant).Optionally, the cardiac treatment system may include one or moreadditional features described in detail herein.

Further embodiments described herein include a method of treating heartvalve insufficiency. The method may include introducing a cardiac deviceinto a patient. The cardiac device can include an implant bodycomprising a mesh material and configured to surround at least a portionof the patient's heart. Also, the cardiac device may include a fillablebladder mounted to the implant body. The method may optionally includepositioning one or more radiopaque markers of the fillable bladder at atargeted exterior region of the patient's heart that is adjacent to atargeted valve structure. Additionally, the method may optionallyinclude one or more additional features described in detail herein.

In some embodiments, a method of treating heart valve insufficiencyincludes introducing a cardiac implant into a patient. The cardiacimplant may include an implant body, which can optionally be formed intoa generally tubular configuration. The implant body may include aleading end portion with an open leading end and a trailing end portionwith an open trailing end. The cardiac implant may also include afillable bladder attached to the implant body. The method may alsoinclude positioning the cardiac implant along an exterior of the heartso that the leading end portion is positioned in an atrial-ventriculargroove of the heart, the trailing end portion of the implant extendsproximal of the apex of the heart, and the fillable bladder positionedadjacent a targeted exterior surface of the heart that is adjacent toselected valve structure. The method may optionally include closing theopen trailing end of the trailing end portion of the implant body sothat the implant body encompasses the apex of the heart. Optionally, themethod may include one or more additional features described in detailherein.

In particular embodiments, a method includes introducing a cardiacimplant into a patient, wherein the cardiac implant may include animplant body and a fillable bladder. The implant body may include ajacket of mesh material and a hem located around a perimeter of an openleading end of the implant body. Optionally, the hem may be formed froma portion of the mesh material and an elastic band surrounded by theportion of the mesh material. The fillable bladder can be attached on aninterior of the mesh jacket. The fillable bladder may include an innerlayer and an adjacent outer layer that is adjacent the mesh jacket. Theinner layer may have a compliance that is greater than a compliance ofthe outer layer. The method may also include positioning the cardiacimplant within the pericardium and external to the epicardium of aheart. Such positioning may occur so that the hem of the implant ispositioned in an atrial-ventricular groove of the heart and the fillablebladder is positioned adjacent a portion of external heart wall that isadjacent to selected valve structure. The method may further includefilling the fillable chamber whereupon the inner layer expands inwardlyto apply localized pressure against the portion of the external heartwall that is adjacent the selected valve structure. Optionally, themethod may include one or more additional features described in detailherein.

In some embodiments, a method may include introducing a cardiac implantinto a patient. The cardiac implant may include an implant body and afillable bladder mounted to the implant body. The fillable bladder mayinclude an inner bladder layer having a compliance that is greater thana compliance of the outer bladder layer. Also, the method may includepositioning the cardiac implant within the pericardium and around theepicardium of a heart so that the inner bladder layer of the fillablebladder is positioned adjacent a portion of external heart wall that isadjacent selected valve structure. The method may include filling thefillable chamber such that the bladder expands more inwardly toward theheart than outwardly away from the heart and applies localized pressureon the external heart wall. Optionally, the method may include one ormore additional features described in detail herein.

Further embodiments described herein include a method for an operator toimplant a cardiac implant for treating heart valve insufficiency. Themethod may include providing a delivery system loaded with a cardiacimplant. The cardiac implant may include an open leading end andconfigured for implantation around external portions of a heart. Thedelivery system may include an implant delivery mechanism comprising aplurality of distally extending elongate members each having a distalend portion attached to a portion of the cardiac implant at or near theopen leading end. The delivery system may further include a proximalhandle assembly comprising a pistol grip. Also, the delivery system mayinclude a control mechanism configured in relation to the plurality ofelongate members for manually extending the plurality of elongatemembers relative to the handle assembly. The method may includeimplanting the cardiac implant with the operator holding the pistol gripof the handle assembly in a first hand, and using a second hand toactuate the control mechanism to extend manually the plurality ofelongate members to advance the open leading end of the cardiac implantover and past the apex of the heart to position the cardiac implantaround external portions of the heart. Optionally, the method mayinclude one or more additional features described in detail herein.

Various embodiments described herein include a method of treating heartvalve insufficiency. The method may include providing a cardiac implantincluding an implant body, an inflatable bladder arranged on the implantbody, and flexible tubing in fluid communication with an internalchamber of the inflatable bladder. The method may also includeimplanting the cardiac implant around external portions of the heartwith the inflatable bladder positioned adjacent a portion of an externalheart wall that is adjacent to a targeted heart valve structure.Further, the method may include inflating the inflatable bladder usingthe flexible tubing. Optionally, the method may include attaching atleast one biodegradable ligation clip to a proximal portion of theflexible tubing to seal an internal lumen of the flexible tubing tomaintain a selected inflation state of the fillable bladder. Also, themethod may optionally include one or more additional features describedin detail herein.

Particular embodiments described herein include a method of making acardiac implant. The method may provide a cardiac implant forimplantation around an exterior of a heart. The method may includeproviding a first plate structure having opening structure on a surfacethereof. The opening structure may accommodating adhesive radiopaquematerial. The method may also include providing a second plate structurehaving two fillable bladder sheet components positioned thereon.Further, the method may include positioning, to provide a cardiacimplant pre-assembly, a portion of a mesh jacket between the first platestructure and the two fillable bladder sheet components positioned onthe second plate structure. The method may also include curing theimplant pre-assembly to attach the radiopaque marker material, providedthrough the opening structure, on one side of the portion of the meshjacket and the two fillable bladder sheet components on an opposite sideof the portion of the mesh jacket. Optionally, the opening structure ofthe first plate structure may include at least one indentation in thefirst plate structure into which the adhesive radiopaque material isprovided. In another option, the opening structure may include at leastone hole through the first plate structure through which hole adhesiveradiopaque material is provided. Optionally, the method may include oneor more additional features described in detail herein.

These and other embodiments described herein may provide one or more ofthe following benefits. First, some embodiments include an implantstructure having a combination of components that operate tocontemporaneously apply forces for supporting or deformation differenttargeted regions of the heart. For example, the implant structure ofparticular embodiments of the system described can be configured tocontemporaneously apply a localized pressure to a defined area of theposterior lateral surface of the heart while also applying a restrainingforce of to the ventricle walls of the heart and (optionally) acompressive supporting force to the atrial-ventricular groove of theheart.

Second, some embodiments of the system or method described herein can beused to treat various heart conditions, including but not limited tofunctional mitral valve regurgitation (“FMR”), tricuspid valveregurgitation, congestive heart failure, or a combination thereof. Uponimplantation, implantation structure can apply forces for supporting ordeformation regions of the heart in a manner that eliminates or reducesthe symptoms of these conditions and that improves blood flow from theheart.

Third, some embodiments of the system or method described herein caninclude a delivery device configured to advantageously advanced theimplant structure to the heart through a relatively small opening of aselected intercostal space proximate to the apex of the heart.Optionally, each delivery device can be configured as a disposable,single-use instrument that is pre-loaded with the implant structure andpackaged in a sterilized kit. As such, the clinician can simply select adelivery device bearing the selected size of implant structure(pre-installed on a barrel of the delivery device by during manufactureor assembly) from a plurality of delivery devices in a hospitalinventory. After the implant structure in implanted, the delivery devicecan be conveniently discarded along with other disposables from theoperating room.

Fourth, in some embodiments, the implant structure can be arranged onthe delivery device in a predetermined orientation relative to thehandle of the delivery device. In such circumstances, the fillablebladder of the implant structure may be predisposed for advancementalong a targeted side of the heart (e.g., a posterior side) when thehandle of the delivery device is held in a selected position external tothe opening in the chest, thereby assisting the clinician in aligningthe fillable bladder with the targeted surface region of the heart.

Fifth, in particular embodiments, the implant structure can be equippedwith radiopaque markers positioned at an advantageous combination oflocations along the leading end, along the fillable bladder, or both. Assuch, during use of the implant structure, the relative positioning ofthe implant structure and the targeted landmarks of the heart can bereadily identified both during and after an implantation procedure.

The details of one or more embodiments of the invention are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages of such embodiments will be apparent from thedescription and drawings, and from the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is an exploded view showing an implant for treating a heart andthe heart upon which the implant may be implanted, in accordance withsome embodiments.

FIG. 1B is a perspective cutaway view of a heart with the implant ofFIG. 1A implanted on the heart.

FIG. 2A is a perspective side view of an implant for treating a heart,in accordance with some embodiments.

FIG. 2B is a perspective end view of the implant of FIG. 2A showing afillable bladder in a deflated configuration.

FIG. 2C is a perspective end view of the implant of FIG. 2A showing thefillable bladder in an inflated configuration.

FIG. 3 is an exploded view of a fillable bladder, in accordance withsome embodiments.

FIG. 4A is a perspective view of another implant for treating a heartthat is positioned on a patient's heart, in accordance with someembodiments.

FIG. 4B is a perspective view of another implant for treating a heartincluding three optional bladder locations at the mitral valve,papillary muscle and tricuspid valve, in accordance with someembodiments.

FIG. 5 is a sectional elevation view through one of the inflatablebladders of FIGS. 4A and 4B.

FIG. 6A is a perspective side view of an implant delivery device that isloaded with an implant, in accordance with some embodiments.

FIG. 6B is a perspective side view of the implant delivery device ofFIG. 6A with a heart stabilizer in an extended position.

FIG. 6C is a distal end view of the implant delivery device of FIG. 6A.

FIG. 7 is a front view of a low friction (e.g., lubricious) stripcomponent for use with the implant delivery device of FIG. 6A, inaccordance with some embodiments.

FIGS. 8A-8E are multiple perspective views of an implant delivery devicewith the heart stabilizer in an extended position, in accordance withsome embodiments.

FIG. 8F is a perspective view of the implant delivery device of FIGS.8A-8E, with the heart stabilizer in a retracted position.

FIG. 8G is a perspective view of the implant delivery device of FIGS.8A-8E, with the heart stabilizer in a retracted position and multipleelongate actuator arms in fully extended positions.

FIG. 9A shows a perspective view of the implant delivery device of FIGS.8A-8E, with one of its elongate arms in a partially extended position.

FIG. 9B is a partial perspective and partial cross-sectional view of theimplant delivery device of FIG. 9A, the cross section taken along lines9B shown in FIG. 9A.

FIG. 9C is a view of a proximal portion of the implant delivery deviceof FIGS. 9A-9B.

FIG. 10 is a perspective view of an actuator arm retainer ring componentof the implant delivery device of FIG. 9A, in accordance with someembodiments.

FIG. 11A is a perspective view of an implant delivery device with anelongate arm in an implant released position that enables the release ofan implant from the elongate arm, in accordance with some embodiments.

FIG. 11B is a perspective view of the implant delivery device of FIG.11A with the elongate arm in an implant clamping position, in accordancewith some embodiments.

FIGS. 12A-12C is a three-part flowchart of an example method forinstalling an implant in a patient to treat a heart condition, inaccordance with some embodiments.

FIGS. 13A and 13B are top and perspective view of a device forfacilitating an open surgical access passageway to the patient's heart,in accordance with some implementations of the method of FIGS. 12A-12C.

FIG. 13C is a perspective view of multiple ones of the device of FIGS.13A and 13B in use on a patient, in accordance with some implementationsof the method of FIGS. 12A-12C.

FIGS. 14A-14C are perspective top and side views of a device formeasuring the size of a heart within the patient, in accordance withsome implementations of the method of FIGS. 12A-12C.

FIG. 15 is a perspective view of the introduction into a patient's chestcavity of an implant that is loaded on an implant delivery device, inaccordance with some implementations of the method of FIGS. 12A-12C.

FIGS. 16A-16C are perspective views of the advancement of an implantonto the patient's heart, in accordance with some implementations of themethod of FIGS. 12A-12C.

FIG. 17 is a perspective view of the withdrawal of an implant deliverydevice after installing an implant on the patient's heart, in accordancewith some implementations of the method of FIGS. 12A-12C.

FIG. 18 is a perspective view of trimming of the implant afterinstalling an implant on the patient's heart, in accordance with someimplementations of the method of FIGS. 12A-12C.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

Referring to FIGS. 1A-1B, some embodiments of a system or methoddescribed herein include an implant structure configured to bepositioned around the exterior of an epicardial surface of a heart H.Such an implant 100 can be used, for example, to treat various heartconditions, including but not limited to FMR, tricuspid valveregurgitation, congestive heart failure, or a combination thereof. Forexample, in the embodiment depicted in FIG. 1B, the implant 100 caninclude a fillable bladder 120 coupled to a mesh body 110 at a specificlocation to exert a localized pressure on the posterior lateral surfaceof the heart H to thereby deflect the “P2” portion of the posteriorleaflet of the mitral valve to treat FMR. The combined components of theimplant 100 can be configured to apply supporting or deformation forcesto multiple targeted regions of the heart H in a manner that supportsthe ventricle walls of the heart, particular valve structures of theheart, and (optionally) atrial-ventricular groove of the heart. In use,the implant 100 can be delivered to the heart H through a relativelysmall opening of a selected intercostal space and thereafter expandedover the apex, ventricles, and atrial-ventricular groove of the heart.In some embodiments, a delivery device (described in detail below) canbe operated by a clinician to install the implant 100 on the beatingheart H at a selected location, which is verified in real time by theclinician in real using radiopaque markers positioned at an advantageouscombination of locations along a hem 113 of the leading end, along thefillable bladder 120, or both.

Referring to FIG. 1A, an implant 100 can be positioned around theexternal surface of a heart H (e.g., external to the epicardium) totreat various heart conditions. Such heart conditions can include, butare not limited to, functional mitral regurgitation (“FMR”), tricuspidvalve regurgitation, and congestive heart failure. FMR is a condition inwhich the valve structures are normal but the heart is in an abnormalconfiguration (e.g., an enlarged heart) wherein valve functioning isdegraded or not optimal. The implant 100 in this embodiment has atubular shape that defines an interior space. The implant 100 can beinstalled onto the heart H such that a portion of the heart H ispositioned within the interior space defined by the implant 100. Forexample, in some implementations the implant 100 is installed so thatsome or all of the left and right ventricles of the heart H arepositioned within the interior space defined by the implant 100. In suchan arrangement, the implant 100 surrounds a perimeter of a portion ofthe heart H. Hence, the implants provided herein, of which implant 100is one example, may also be referred to herein as jackets. In thedepicted embodiment, the implant 100 is of a flexible or expandabletubular design in that it has an open distal end 112 and an openproximal end 119. The open distal end 112 of the implant 100 enables theimplant 100 to be implanted by advancing the open distal end 112 aroundthe heart from an inferior (apex) end of the heart to, for example, anatrial-ventricular groove of the heart (described below in connectionwith FIG. 1B). The open proximal end 119 of the implant 100 is presentin the depicted embodiment to accommodate a minimally invasive deliverydevice (described below in connection with FIGS. 6A-6C) with one or moremembers that extend through the open proximal end 119 and attach to theopen proximal end 119 of the implant 100 so as to push the distal end112 of the implant 100 over and beyond the apex of the heart H and into,for example, the atrial-ventricular grove, as will be shown anddescribed below.

In some embodiments, the implant 100 can include a tubular mesh body110. The tubular mesh body 110 may include one or more seams 111 thatare formed as a result of the construction of the tubular mesh body 110.For example, the one or more seams 111 may be formed as a result ofmaking the mesh body 110 into a tube, as a result of creating contourswithin the mesh body 110, or as a result of creating hemmed ends of themesh body 110. However, seams are not a requirement in all embodimentsof the implant described herein. That is, in some alternativeembodiments, the implant can be made with a seamless construction.

Still referring to FIG. 1A, a fillable bladder 120 is attached to themesh body 110. The fillable bladder 120 may also be referred to hereinas an inflatable bladder. In this embodiment, the fillable bladder 120is affixed on an interior surface of the mesh body 120. Hence, when theimplant 100 is installed onto the heart H (e.g., between the pericardiumand epicardium), the fillable bladder 120 is positioned adjacent to andmakes contact with the external surface of the heart H. In somealternative embodiments, the fillable bladder 120 can be affixed on theexterior of the mesh body 110, or installed in or between layers ofmaterial of a multi-layered mesh body. In further alternativeembodiments, multiple fillable bladders 120 are affixed on a single meshbody 120.

An inflation tube 130 is in fluid communication with the fillablebladder 120. As described further herein, the inflation tube 130provides a lumen through which an inflation fluid (e.g., saline oranother biocompatible liquid) is transferred to thereby inflate ordeflate the fillable bladder 120. In some embodiments, one or moreligation clips 140 are used to seal the inflation tube 130 after thefillable bladder 120 has been filled with an inflation fluid to adesired extent. As an alternative to the ligation clips 140, theinflation tube 130 can be doubled over to seal the inflation tube 130,and the configuration can be secured by tightly wrapping thedoubled-over portion with a suture. In another alternative, a plug canbe inserted into the end of the inflation tube 130. Other techniques anda combination of techniques can also be used to seal the proximal regionof inflation tube 130. With the one or more ligation clips 140 installedon the inflation tube 130, the selected amount of inflation fluid can bemaintained within the fillable bladder 120. With the fillable bladder120 thusly inflated, the expansion of the bladder 120 causes a localizedpressure to be applied to a selected exterior surface of the heart H(e.g., along an exterior of the epicardium), to thereby treat a heartcondition.

The implant 100 can also include a plurality of radiopaque markers 115and 125 in selected locations that provide a number of benefits to asurgeon during and after implantation. Such radiopaque markers 115 and125 can facilitate radiographical visualization of the implant 100during a minimally invasive implantation process. For example, in someinstances the implant 100 is installed with the assistance offluoroscopy. Other imaging modalities may also be used, such asechocardiography, Mill, and the like. Using imaging systems inconjunction with radiopaque markers 115 and 125, the implant 100 can bepositioned onto the heart H, and oriented in relation to anatomicalfeatures of the heart H, as desired. In some implant procedures,contrast agent solutions are injected into the heart, or within thepericardial space, to enhance the radiographical visualization ofanatomical features of the heart H on which an implant 100 is to beinstalled. The radiopaque markers 115 and 125 can comprise materialssuch as, but not limited to, tantalum, platinum, tungsten, palladiumalloys, and the like.

In the embodiment shown, a first group of radiopaque markers 115 arepositioned at a leading end 112 of the mesh body 110. The leading end112 in this embodiment includes a circumferential hem region thatdefines the distal end opening 117 (refer to FIG. 2A). As describedfurther herein, in some embodiments the radiopaque markers 115 are usedto facilitate the installation of the implant 100 in relation to theheart H such that the leading end 112 is positioned in theatrial-ventricular groove of the heart H. A second group of radiopaquemarkers 125 are positioned on the implant 100 to identify the locationof the fillable bladder 120 on the mesh body 110. For example, thesecond group of markers 125 can be mounted along at least a portion of aperiphery of the fillable bladder 120. Using the radiopaque markers 125,the fillable bladder 120 can be positioned at a target location on theexterior surface of the heart H. For example, as will be describedfurther herein, in some instances the fillable bladder 120 may beconfigured for installation at a selected position on the surface of theheart H (for example, on a posterior wall of the heart adjacent themitral valve) so that the fillable bladder 120 will exert a localizedpressure to induce the reshaping of a portion of the heart H when thefillable bladder 120 is inflated. In the case of positioning on aposterior wall of the heart adjacent the mitral valve, the fillablebladder 120 provides localized pressure that in turn is applied to aposterior portion of the mitral valve annulus, thus bringing theleaflets of the valve into closer proximity with one another andaddressing a mitral valve regurgitation problem (described, for example,in more detail below in connection with FIG. 1B). While this embodimentincludes the radiopaque markers 115 and 125 located near the leading end112 and fillable bladder 120 respectively, in other embodimentsradiopaque markers may be included at other locations instead of, or inaddition to, the locations of the radiopaque markers 115 and 125.

Still referring to FIG. 1A, the mesh body 110 of the implant 100 alsoincludes a trailing end portion 118 that is located opposite of theleading end 112. The trailing end portion 118 may also be referred toherein as the proximal region. The trailing end portion 118 can providethe implant 100 with an axial length such that, when the implant 100 isinstalled on the heart H, excess mesh material extends proximally awayfrom the apex A of the heart H. As described in detail below, afterinstalling the implant 100 onto the heart H, an excess length portion ofthe trailing end portion 118 can be optionally trimmed off of theimplant 100. Thereafter, in some implementations the trimmed end of themesh body 110 at the trailing end portion 118 is gathered or cinchedaround the apex A and closed using one or more sutures, clips, or thelike. This implementation of providing a post-installation closure tothe trimmed end of the mesh body 120 may be preferred in some cases, forexample, to prevent the proximal end of the implant 100 from migrating,after implantation, distally toward the distal end of the implant 100,which may otherwise occur given the movement of the heart and the lesserdegree anchoring of the implant 100 immediately after installation(before fibrosis and tissue ingrowth between the implant 100 and theheart tissue such as the epicardium, pericardium, or both).

Referring now to FIG. 1B, the implant 100 can be installed on the heartH so as to surround an inferior portion of the heart H, including atleast a portion of the left and right ventricles V. In some embodiments,at least a portion of the leading end 112 is positioned in theatrial-ventricular groove of the heart H. By positioning the leading end112 in the atrial-ventricular groove AV, the implant 100 can maintain adesired positioning in relation to the heart H by taking advantage ofthe contours of the heart H. In this embodiment, the implant 100 isinstalled in the pericardial cavity. That is, during the implantationprocess, the pericardium is opened and the implant 100 is installed overan exterior of the epicardium of the heart H and internal to thepericardium of the heart H. Thereafter, the pericardium is closed tothereby contain the implant 100 in the pericardial cavity. Over time, afibrosis or tissue ingrowth process may occur to cause the mesh body 110to be anchored to the epicardium, the pericardium, or a combinationthereof. Optionally, in some instances, one or more sutures may be usedto attach the mesh body 110 to the epicardium at the time ofimplantation.

In the depicted embodiment, the fillable bladder 120 is attached to aninterior surface of the mesh body 110 such that, when the implant 100 isimplanted, the fillable bladder 120 is positioned between the mesh body110 and the heart H. In other words, a surface of the fillable bladder120 is in direct contact with a surface of the heart H (e.g., anexterior epicardial surface in this embodiment). When an inflation fluidis supplied under pressure into the fillable bladder 120 (e.g., from asyringe device coupled to the inflation tube 130), the fillable bladder120 expands from a collapsed condition to an operative condition tothereby exert a localized pressure to a targeted portion of the surfaceof the heart H. A target location for applying the localized pressurecan be strategically selected to induce a desired effect to thepatient's heart H. For example, as shown, a localized pressure can beexerted at a location on the heart H that causes a deflection to anannulus of a heart valve HV, such as a mitral valve or a tricuspidvalve. In that manner, some types of valvular regurgitation can betreated. In a particular example, the fillable bladder 120 can bepositioned to exert a localized pressure on the posterior lateralsurface of the heart H to thereby deflect the “P2” portion of theposterior leaflet of the mitral valve to treat FMR. In another example,other areas on the exterior surface of the ventricles V can be targetedfor the exertion of a localized pressure from the fillable bladder 120.In some such examples, the papillary muscles P are advantageouslydeflected. In certain instances, such deflecting of the papillarymuscles P, and the chordae tendineae CT confluent therewith, can alsotreat valvular regurgitation.

While the examples of FIGS. 1A and 1B depict an implant 100 having asingle fillable bladder 120, it should be understood that in otherembodiments two or more fillable bladders may be included on a singleimplant device. In the depicted embodiment, the fillable bladder 120 ispre-attached to the mesh body 110. In some embodiments, one or morefillable bladders are separate from the mesh body, and are attached tothe mesh body or positioned at a desired location inside the mesh bodyduring the implantation procedure either before or after the mesh bodyhas been installed on the heart. For example, the mesh body may beinstalled on the heart H of a patient, and subsequently one or morefillable bladders can be positioned at target locations in relation tothe mesh body and then optionally attached to the mesh body in situ.

In some embodiments, the mesh body 110 is sized to snugly fit on theheart H, but not so tight as to cause a significant increase in leftventricular pressure during diastole or obstructions to the coronaryarteries or other vessels such as the coronary sinus. That is, in theseembodiments, the mesh body 110 is designed to be highly compliant to theshape of the heart H, and adaptable to gently conform with thedistension of the myocardium as the heart H performs pumping actions.

Referring to FIGS. 2A-2C, the implant 100 of FIG. 1 will now bedescribed in greater detail. FIG. 2A provides a perspective viewillustrating the tubular shape and other features of the implant 100.FIGS. 2B and 2C provide end perspective views to illustrate, forexample, the interior surfaces of the implant 100 and the fillablebladder 120. For instance, FIG. 2B depicts the fillable bladder 120 in adeflated configuration, while FIG. 2C depicts the fillable bladder 120in an inflated configuration.

In some embodiments, the material of the mesh body 110 is constructedfrom a knitted, biocompatible material. In particular embodiments, theknitted material is made using a construction known as “Atlas knit.” TheAtlas knit is a knit of fibers having directional expansion properties.More specifically, the knit, although formed of generally inelasticfibers, permits a construction of a flexible fabric at least slightlyexpandable beyond a rest state. The fibers of the mesh fabric are woveninto two sets of fiber strands. The strands are interwoven to form thefabric with a first set of strands generally parallel and spaced-apartand with a second set of strands generally parallel and spaced-apart.For purposes of illustration in FIGS. 2A-2C, the mesh fabric isschematically shown herein as a diamond-shaped open cell mesh fabrichaving diagonal axes, but it should be understood from the descriptionherein that the mesh fabric may have a different appearance. FIGS. 1Aand 2A illustrates the knit mesh body 110 in a generally unexpandedstate, whereas FIG. 1B illustrates the knit mesh body 110 is an expandedstate. In some embodiments, the mesh body 110 is made of a Denierpolyester. In other embodiments, the mesh body 110 can be made of othersuitable biocompatible materials including polytetrafluoroethylene(PTFE), expanded PTFE (ePTFE), polypropylene, stainless steel, and thelike, or combinations thereof. Other types of knitting processes canalso be used to construct the implants provided herein. Further, otherconstruction techniques in addition to knitting are envisioned. Forexample, some or all parts of the body 110 may be woven, braided, madeof tubing or an expanded tubing, and the like.

In some embodiments, the mesh body 110 includes a leading end portion114, a transition portion 116, and a trailing end portion 118. Each ofthe three portions 114, 116, and 118 are tubular. That is, the meshmaterial used to construct the portions 114, 116, and 118 is arranged todefine open interior spaces. In this embodiment, the mesh body 110 isconfigured to provide a cross-section shape (e.g., perpendicular to acentral axis of the implant 100) that is circular in each of the threeportions 114, 116, and 118, and the portions 114 and 118 may begenerally cylindrical along a majority of their respective axiallengths. In other embodiments, the materials can be arranged to defineother cross-sectional shapes. In other embodiments, other configurationsof implant body shapes are envisioned, and such portions 114, 116, and118 are not necessarily implemented in all embodiments described herein.In some embodiments, the construction of the mesh body 110 may includeone or more seams 111 as a result of sewing the mesh material into thedesired shape. In some embodiments, the construction of the mesh body110 may be seamless.

Still referring to FIGS. 2A-2C, in this embodiment, the generallycylindrical leading end portion 114 provides the largest diameter of thethree portions 114, 116, and 118 (when the implant 100 is in anon-stressed state prior to implantation). In some embodiments, thethree portions 114, 116, and 118 are not separately constructed regions,but rather are defined regions of a device constructed from a singlepiece of mesh material. In other embodiments, the three portions 114,116, and 118 may be separately constructed and attached together to formthe final implant construction. The trailing end portion 118 providesthe smallest diameter of the three portions 114, 116, and 118 (when theimplant 100 is in a non-stressed state prior to implantation). Thetransition portion 116 extends between a proximal end periphery of theleading end portion 114 and a distal end periphery of the trailing endportion 118. The transition portion 116 has diameter variance from itsdistal end portion to its proximal end portion. That is, the transitionportion 116 may be tapered (providing either a linear taper or a curvedtaper), extending proximally from the leading end portion 114 whiledecreasing in diameter to join with the distal end periphery of thetrailing end portion 118. In some embodiments, the transition portion116 comprises a frustoconical shape. In particular embodiments, some orall of the transitional region 116 has a radiused profile to providesmooth transitions to the leading and trailing portions 114 and 118.

In some embodiments, at least a portion of the leading end portion 114has a diameter and construction for positioning around a heart in theatrial-ventricular groove AV of the heart H. For example, a hem 113comprising an elastic band member may be configured for positioningaround an atrial-ventricular groove AV (refer to FIG. 1B), to therebyreleasably affix the leading end 112 to the heart H. The diameter of thehem 113 (including the elastic band member) may be selected in relationto the size of the heart of a patient. The selected diameter of the hem113, at rest, will be smaller than the perimeter of the heart at theatrial-ventricular groove, to provide an interference fit therebetween.The high compliance and elasticity of the hem 113 (including the elasticband member) facilitates an interference fit that is effective formaintaining the implant 100 in the targeted position on the heart Hwhile not detrimentally constricting the heart and vessels on theoutside of the heart such as the coronary artery or coronary sinus overwhich the hem 113 may be positioned when the implant 100 is implanted.

Portions of the leading end portion 114, other than the hem 113, areconfigured for circumferentially encompassing upper portions of theheart ventricles. In addition, some or all of the transition portion 116may be configured for circumferentially encompassing other portions theheart ventricles. Most or all of the trailing end portion 118 may beconfigured to extend proximally from the apex of the heart when theleading end 112 is positioned in the atrial-ventricular groove. Afterinstallation of the implant 100 on a heart, some or all of the trailingend portion 118 may be trimmed away and removed from the implant 100.Thereafter the trimmed proximal end of the implant 110 may gathered orcinched and closed around the apex of the heart. Closing the proximalopen end prevents the implant 100 from migrating toward the superiorregions of the heart after implantation. In this manner, the implant 100can be tailored to fit the patient-specific size and contours of theheart on which the implant 100 is installed.

Multiple sizes of implants 100 are envisioned that are suitable fortreating multiple sizes of hearts. For example, the diameters of some orall of portions 114, 116, and 118 can be available in incremental sizes.In some embodiments, the axial lengths of some or all of portions 114,116, and 118 are also configured in incremental sizes. As will bedescribed further herein, an implant 100 of a particular size can beselected for a patient based on a pre-operative measurement of thepatient's heart. For example, in some instances a measurement is takenof the patient's largest ventricular perimeter, and that measurement isused to select the size of implant 100 to be used for that patient. Aswill be described further herein, various sizes of implants 100, each ofwhich is preloaded on an implant delivery device (refer to FIGS. 5-7),can be available to a clinician, and the clinician can select aparticular size of implant 100 based on the measurement of the patient'sheart. In some embodiments, a particular size of implant 100 can be usedfor a range of heart measurement values. For example, a particular sizeof implant 100 may be used for a range of maximum ventricular perimetersof 36.9 cm to 40.0 cm. Another size of implant 100 may be used for arange of maximum ventricular perimeters of 40.1 cm to 43.4 cm. Stillanother size of implant 100 may be used for a range of maximumventricular perimeters of 34.0 cm to 36.8 cm, and so on. It should beunderstood that these ranges of maximum ventricular perimeters providedare merely illustrative, and are non-limiting examples. In addition, thecombination of mesh material compliance and size, hem constructionincluding the compliance of an elastic band on the hem 113, and fillablebladder construction include the compliance of materials used toconstruct together may be selected in accordance with the teachingsherein to achieve implant design configurations that enable a fewernumber of sizes for a wide range of heart sizes, thereby achievinginventory cost benefits. In some embodiments, the trailing end portion118 is configured to have the same diameter across all sizes ofimplants. The fillable bladder 120 may also be implemented with varioussizes. For example, larger fillable bladders may be used with largersized implants, and smaller fillable bladders may be used with smallersized implants.

Still referring to FIGS. 2A-2C, the leading end 112 in this embodimentis defined by the hem 113. In some embodiments, the hem 113 can beconstructed by wrapping some of the mesh material at the distal end ofthe leading portion 114 around the elastic band, and then securing thefree end of the material to an interior portion of the leading endportion 114. Such securing may be continuous or in multiple discreetsections. In particular embodiments an elastic hem band material can becontained within the doubled over layers of mesh material. The elastichem band material can be made of a low durometer silicon elastomermaterial, or any other suitable elastic biocompatible material. Thediameter of the elastic hem band material, at rest, may be less than theat rest diameter of the mesh material at the hem 113. By way of example,in some embodiments the circumference of the mesh material, at rest, inthe hem 113 may be about 25 centimeters, whereas the length of theelastic hem band material may be about 20 centimeters. Such aconfiguration may accommodate, by way of example only, a heart sizewherein the atrial-ventricular groove may be about 30 centimeters incircumference. Owing to the length of the elastic band being longer thanthe circumference of the mesh material at the hem 113, the mesh materialat the hem 113 may be gathered in a slightly wavy or “bunched”configuration about the internal elastic member when the hem 113 is notbeing stretched around the heart H. In some alternative embodiments, theinternal elastic band may not be implemented, and in such cases, themesh material may be configured into a reduced diameter region in thehem area so as to enable an interference fit of the hem area into anatrial-ventricular groove. In other alternative embodiments, the elasticband serve as the hem 113 and distal end 112 with the mesh materialwrapping around it, and in such cases, the mesh material may be bondedto a proximal periphery of the elastic band. Optionally, the trailingend 119 may also be hemmed, and the hem of the trailing end 119 may ormay not include an elastic member.

As previously described, some embodiments of the implant 100 includemultiple radiopaque markers 115 located around the hem 113 and multipleradiopaque markers 125 located around the periphery of the fillablebladder 120. As described previously, various types of radiopaquemarkers can be used. In some embodiments, the radiopaque markers 115 and125 have an adhesive quality during manufacture of the implant 100 thatcan be used advantageously during the construction of the implant 100.For example, the second group of radiopaque markers 125 can be adheredto the mesh body 110 and, via the interstitial spaces of the mesh,adhered to the fillable bladder 120 to thereby affix the fillablebladder 120 to the implant 100. In one such embodiment, the radiopaquemarkers 125 (and 115) can be made from raw materials such as a siliconeadhesive paste mixed with powdered tantalum. During manufacturing of theimplant 100, the mixture can be injected into depressions residing in ametal plate, and that are configured in a generally rectangular patternas defined by the radiopaque markers 125 shown in the implant 100. Themetal plate can thereby act as a mold for forming the radiopaque markers125. The mesh body 110 can be placed over the metal plate in anorientation that will position the fillable bladder 120 as desired inrelation to the mesh body 110. The fillable bladder 120 can be placed ontop of the mesh body 110 in an orientation so as to locate theradiopaque markers 125 around the periphery of the fillable bladder 120.A second metal plate can be positioned over the fillable bladder 120.The second metal plate may have a depression that corresponds to thefillable bladder 120. The stacked assembly can then be heated to curethe silicone adhesive paste. In the process, the radiopaque markers 125become adhered to the mesh body 110 and to the fillable bladder 120. Inthis manner, the radiopaque markers 125 can be used to affix thefillable bladder 120 to the mesh body 110. Using a similar technique,the radiopaque markers 115 can be formed and adhered to the exteriorlayer of the mesh material of the hem 113, and adhered to the internalelastic band of the hem 113. Furthermore, the elastic band can therebybe “staked” in relation to mesh material of the hem 113 at the locationsof the radiopaque markers 115. In other embodiments, the fillablebladder 120 and/or elastic band of the hem 113 can be affixed to themesh body 110 using other bonding techniques, such as adhesives,mechanical clips, sutures, interweaving, ultrasonic welding, RF welding,and the like.

Still referring to FIGS. 2A-2C, the implant 100 includes the fillablebladder 120, which as previously described, can be used to exert alocalized pressure on a surface of the heart to induce a therapeuticdeflection thereto. FIG. 2B illustrates the fillable bladder 120 in adeflated state, and FIG. 2C illustrates the fillable bladder 120 in aninflated state. While the fillable bladder 120 depicted in FIGS. 2A-2Cis generally rectangular in shape, other shapes of fillable bladders arealso envisioned. For example, fillable bladders can be circular,elliptical, semi-toroidal, triangular, linear, pyramidal, irregularlyshaped, and any other like shape, or combinations of shapes.

As previously described, the inflation tube 130 is in fluidcommunication the fillable bladder 120. The inflation tube 130 is of aflexible tubular construction and is configured to remain in thepatient's body as part of the implant 100, and to remain in fluidcommunication with the fillable bladder 120. The free end of theinflation tube 130 can be positioned subcutaneously, and near to theunderside of the epidermis. In some implementations, the free end of theinflation tube 130 is located in an intercostal space after implantationof the mesh body 110 around the heart. So locating the free end of theinflation tube 130 may allow future access to the inflation tube 130 viaa simple cut-down procedure through the skin adjacent to the intercostalspace between the ribs (e.g., the fifth intercostal space in someimplementations). Future inflation or deflation of the fillable bladder120 may thereby be performed with a minimally invasive access to anintercostal space under the side without extensive surgery to access thepericardium or epicardium.

In some embodiments, the flexible inflation tube 130 is made ofsilicone, but other biocompatible materials may also be used. In someembodiments, the outer diameter of the inflation tube 130 can range fromabout 0.065 inches to about 0.25 inches (about 1.60 mm to about 6.40mm). In one example embodiment, the outer diameter of the inflation tubeis about 0.125 inches (about 3.2 mm). In some embodiments, the innerdiameter of the inflation tube 130 can range from about 0.031 inches toabout 0.125 inches (about 0.78 mm to about 3.18 mm). In one exampleembodiment wherein the outer diameter of the inflation tube is about0.125 inches (about 3.2 mm), the inner diameter of the inflation tube isabout 0.0625 inches (about 1.58 mm). Such inflation tube dimensions areprovided as examples, and it should be understood that other sizes arealso envisioned within the scope of this disclosure. In addition, thecross-sectional sizing of the inflation tube may be selected toaccommodate the specific inflation material (and in some casesradiopaque contrast agent) that will flow through the tube (discussedbelow).

The inflation tube 130 provides a flexible conduit through whichinflation fluid can be conveyed to inflate or deflate the fillablebladder 120. After inflating or deflating the fillable bladder 120 witha selected volume of inflation fluid, the proximal end region of theinflation tube 130 is sealed to prevent withdrawal of the inflationfluid from the fillable bladder 120. Various types of inflation fluidscan be used. For example, the inflation fluid can be a saline liquidsolution, silicone gel, gaseous substances, and fluids containing acontrast agent that facilitate visualization of the inflation fluid viaimaging systems.

In some embodiments, the fillable bladder 120 is configured of twodifferent sheet components 122 and 124 so that the bladder 120, wheninflated, expands more interiorly (that is, toward the heart wall whenimplanted) than exteriorly. As such, the bladder 120 is configured toprovide a differential compliance in which one surface of a bladder 120is significantly more compliant than the opposing (less compliant)surface of the bladder 120. In the context of fillable bladder 120, theinterior sheet component 122 of the fillable bladder 120 is morecompliant than the outer sheet component 124 of the fillable bladder120. When the implant 100 is installed on a heart, the heart is locatedwithin the interior region of the mesh body 110 and in contact with theinterior sheet component 122 of the fillable bladder 120. The greatercompliance of the interior sheet component 122 of the fillable bladder120 (in relation to the lesser compliance of the outer surface material)can accentuate the localized pressure applied onto the surface of theheart when the fillable bladder 120 is inflated.

Referring now to FIG. 3, some embodiments of the fillable bladder 120can include the two different sheet components 122 and 124 in the formof an interior sheet component 122 and an outer sheet component 124. Achamber for containing fluids can be formed therebetween by hermeticallysealing together the periphery of the sheet components 122 and 124. Asdiscussed above, this sealed periphery of the bladder 120 is the portionof the bladder 120 to which the radiopaque markers 115 are attachedthrough spaces in the mesh material interposed between the bladder 120and the markers 115. In this embodiment of the bladder 120 shown in FIG.3, the sheet components 122 and 124 are sealed together using a bondingagent 126, but other techniques are also envisioned, such as ultrasonicwelding, solvent bonding, a molded monolithic bladder, and the like. Anend portion of the inflation tube 130 is also sealed between the sheetcomponents 122 and 124, such that the lumen of the inflation tube 130 isin fluid communication with the resulting chamber of the fillablebladder 120. In some embodiments, a fitting may be used to couple aninflation tube to a fillable bladder.

The material of the interior sheet component 122 can be selected to havea higher compliance than the material selected for the outer sheetcomponent 124. The interior sheet component 122 can be made of asilicone sheet material, or other biocompatible airtight sheetmaterials. In some embodiments, the thickness of the interior sheetcomponent 122 is in the range of about 0.005 inches to about 0.050inches (about 0.12 mm to about 1.30 mm). In one example embodiment, theinterior sheet component 122 is a silicone sheet material that is about0.015 inches (about 0.38 mm) in thickness. The outer sheet component 124can also be made of a silicone sheet material, or other biocompatibleairtight sheet materials. In some embodiments, the material of the outersheet component 124 can be reinforced (e.g., with a polyester mesh thatis impregnated into the sheet) to resist deformation, thereby reducingthe compliance of the outer sheet component 124. In some embodiments,the thickness of the outer sheet component 124 is in the range of about0.005 inches to about 0.070 inches (about 0.12 mm to about 1.78 mm). Inone example embodiment wherein the interior sheet component 122 is asilicone sheet material that is about 0.015 inches (about 0.38 mm) inthickness, the outer sheet component 124 is a reinforced silicone sheetmaterial that is about 0.020 inches (about 0.51 mm) in thickness.

Various sizes of inflatable bladders 120 can be constructed, anddifferently sized inflatable bladders 120 can be used with differentlysized implants. In some embodiments, the length and width dimensions ofthe sheet components 122 and 124 (including the peripheral regions ofthe membranes that are sealed together) can be in a range from about 0.5inches to about 4.0 inches (about 12.7 mm to about 101.6 mm). In oneexample embodiment, the length and width dimensions of the membranes 122and 124 are in a range from about 1.075 inches to about 2.265 inches(about 27.30 mm to about 57.53 mm). In some embodiments, the fillablebladder 120 has a peripheral seal that is about 0.25 inches (about 6.35mm) wide, and the sheet material within the peripheral seal is theinflatable portion.

In this embodiment, the peripheral bonding of the sheet components 122and 124 can be accomplished using the bonding agent 126. The bondingagent 126 can cross-link with the materials of the sheet components 122and 124 when the bonding agent 126 and sheet components 122 and 124 areheat-soaked as an assembly. In one example, the assembly is heat-soakedat about 350 F (about 177 C) for about 2 hours. Other heat-soaking timeand temperature combinations can also be used, and lower temperatureswill tend to require longer durations (and vice versa). Various types ofbonding agents 126 can be used. In a preferred embodiment, the bondingagent 126 is a non-vulcanized silicone sheet that is about 0.010 inches(about 0.25 mm) thick. After the bonding of the inner and sheetcomponents 122 and 124, and the inflation tube 130, the fillable bladder120 can be leak tested to confirm that the fillable bladder 120 ishermetically sealed.

Upon implantation and proper positioning of the fillable bladder 120with respect to targeted heart H structure(s), the fillable bladder 120(and specifically the bladder's interior sheet component 122) is locatedand bears against an outer epicardial wall of the heart H, and the meshmaterial of the mesh body 110 that is located exteriorly of the bladder120 faces outwardly and bears against the pericardium. When the bladder120 is inflated, the interior sheet component 122 of the bladder 120expands inwardly (e.g., expansion from a reference plane defined asextending through the sealed periphery region of the bladder 120) moreso than the outer sheet component 124 of the bladder 120 expandsoutwardly from this reference plane. This characteristic is accentuatedin larger bladder embodiments in comparison to smaller bladderembodiments. Therefore, design selections, including interior and outersheet properties as well as bladder size and other parameters, can bemade to attain a fillable bladder with the desired expansioncharacteristics.

The combination of the implant's mesh body 110 located exteriorly of thebladder 120 (which provides an circumferential restraint force to urgethe bladder 120 toward the heart H) and the presence of the pericardiumthat surrounds the heart H (the pericardium providing a bearing surfaceagainst which the implant's mesh material and hence the outer sheetcomponent 124 of the bladder 120 bears) collectively resist outwardmovement of the bladder 120. This resistance to outward movement of thebladder 120 from the heart H also contributes so that the interior sheetcomponent 122 of the bladder provides localized pressure upon thetargeted surface region of the heart. This localized pressure deformsnot only the targeted surface region of the heart wall, but also valvestructures located inside the chambers of the heart in the location ofthe localized pressure (refer to FIG. 1B). In addition, at some point intime after implantation (typically in about 1 week to 3 weeks), the meshbody 110 makes a fibrous attachment to both the epicardial wall and tothe pericardium. This fibrous attachment of the mesh body 110 to boththe epicardial wall and the inner wall of the pericardium increases theresistance to outward movement of the bladder 120, thereby increasingthe degree to which the inward expansion of the interior sheet component122 of the bladder 120 provides localized pressure upon the targetedsurface region of the epicardial wall that lies adjacent the bladder120.

FIGS. 4A and 4B show alternative embodiments having one or moreinflatable bladders, as follows. In FIG. 4A, the inflatable bladder ispositioned adjacent to the patient's mitral valve. FIG. 4B showsadditional placement locations of bladders adjacent to the papillarymuscle and tricuspid valve. It is to be understood that the descriptionherein encompasses embodiments with only one or with more than oneinflatable bladder. Thus, FIGS. 4A and 4B simply show preferredlocations for the bladder placement(s).

As seen in FIGS. 4A-B and 5, the depicted embodiment provides anassembly making up an implant 1 wherein the assembly comprises: a jacket10 and at least one inflatable bladder 20. Jacket 10 is made of aflexible biocompatible material and has an open top end 12 that isreceived around the heart H and a bottom portion 14 that is receivedaround the apex A of the heart. In optional aspects, jacket 10 may bemade of a knit mesh. This knit mesh may optionally be made of a polymer,including but not limited to high-density polyethylene. Alternatively,jacket 10 may be made of metal.

In one example embodiment, jacket 10 is made of a suitable knitmaterial. An example of such a knit material may be “Atlas Knit”material described above. Alternatively, jacket 10 may be elastic.Optionally, the fibers may be made of Denier polyester. However, othersuitable materials, including but not limited to, PTFE, ePTFE,polypropylene and stainless steel may also be used. Advantages of usinga knit material include flexibility, fluid permeability and minimizingthe amount of heart surface area in direct contact with the jacket(thereby minimizing the potential of scar tissue development).

Inflatable bladder 20 is disposed on an interior surface of jacket 10.Bladder 20 may or may not be attached to jacket 10. FIG. 4B illustratesthree separate inflatable bladders 20, one being located near a hem ofthe implant 1 and being positioned on a posterior portion of the heart Hwall adjacent the mitral valve (bladder 20A), one being located awayfrom the hem for positioning to a portion of the heart H wall adjacentto a papillary muscle (bladder 20B), and one being located also near ahem of the implant 1 and positioned on an anterior portion of the heartH wall adjacent the tricuspid valve (bladder 20C). In embodimentswherein the bladder 20 is attached to the jacket 10 prior toimplantation of the implant 1, the implant may include one, two or allof the three bladders 20A-C depicted in FIG. 4B. As such, FIG. 4Bdepicts the different locations where a bladder 20 may be located,wherein some embodiments may include only one or two bladders 20positioned on the jack 10 so that the bladder 10 may be positioned atthe depicted locations shown in FIG. 4B. When bladder 20 (that is,bladder 20A in FIG. 4B) is positioned adjacent to the mitral valve, itis preferably positioned at the P2 area of the valve (in the center ofthe posterior leaflet) to reduce the distance across the valve, therebyreducing the gap in the valve responsible for the regurgitation. Whenbladder 20C is positioned adjacent to the tricuspid valve, it performs asimilar function, reducing regurgitation through the tricuspid valve.When bladder 20B is positioned adjacent to the papillary muscle, itgently corrects papillary muscle position and relieves tension on thechordae (which otherwise prohibits normal valve functioning).

As seen in FIG. 5, inflatable bladder 20 has an inelastic outer surface22 positioned adjacent to jacket 10 and an elastic inner surface 24positioned adjacent to the heart H, as discussed previously inconnection with other embodiments. Bladder 20 may optionally be made ofsilicon. In some embodiments, jacket 10 is relatively non-compliant incomparison to the elastic inner surface 24, the outer surface 22 ofbladder 20 positioned adjacent to the bladder is also relativelynon-complaint, and the inner surface 24 of bladder 10 is elastic. As aresult and as described above, when inflated through fluid supply line25, inflation of bladder 20 causes the bladder to deform substantiallyinwardly (i.e.: towards the heart). This then exerts localized pressureagainst a region of the heart. As can be seen, supply line(s) 25 arepositioned inside jacket 10 and extend out of an open bottom end 13 ofthe jacket adjacent to the apex of the heart. Bottom end 13 may becinched (and/or sewn) closed after the jacket 10 has been positionedaround the heart.

As discussed previously, bladder 20 may be inflated with fluidsincluding air, inert gasses (such as fluorocarbons), silicone gel,saline and contrast agents. Supply lines 25 may optionally be inflatedthrough a blunt needle port, a Luer port fitting, a subcutaneous port26, etc. In other embodiments, a port-type device may not be used, andinstead, the supply lines may be clamped in a closed position, asdescribed previously. Supply lines 25 are made of a suitablebio-compatible material, including but not limited to silicone. Thisdocument includes a disclosure of various mechanisms for inflating anddeflating bladders 20 post-implementation. For example, in one approachthe device is first received onto the heart. After a period of time(e.g.: 30 days) fibrotic encapsulation of mesh jacket 10 will haveoccurred. At this time, the bladder(s) 20 can then be inflated (throughsupply line 25 using a needle to percutaneously access filling reservoir26). Thus, subcutaneous ports 26 may be employed for percutaneousinflation and deflation for therapy optimization or abandonment.Alternatively, and because in some cases implanted subcutaneousport-type devices may have potential drawbacks, clamping of the fluidpath tube may be done, with the fluid path staying in the intercostalspace and may be accessed by a small “cut-down” procedure to access thetube.

In optional embodiments, jacket 10 has an elastic band 14 passing aroundits top end 12, as described previously. In addition, radiopaque markers15 can also be provided around top end 12 of the implant 1.

The present jacket and bladder implant system 1 can be placed around thepatient's heart in a variety of different approaches. In an examplemethod of use, the present system further includes a delivery device forpositioning the jacket onto the heart, as described later in thisdocument. In one example of the method described later in this document,the assembly is implanted into the patient in a left intercostalmini-thoracotomy using contrast pericardiography and fluoroscopicvisualization. After opening the parietal pericardium, the lower portionof the heart is free for applying the jacket over the apex.

In some embodiments, methods of providing localized pressure to a regionof a patient's heart H to improve heart functioning may be performed by:(a) positioning an assembly around a patient's heart, wherein theassembly comprises a jacket 10 and at least one inflatable bladder 20,wherein jacket 10 is made of a flexible biocompatible material having anopen top end 12 that is received around the heart and a bottom portion14 that is received around the apex of the heart, and the inflatablebladder 20 is disposed on an interior surface of the jacket, and theinflatable bladder 20 has an inelastic outer surface positioned adjacentto the jacket and an elastic inner surface. In addition, bladder 20 maybe inflated causing it to expand such that the bladder deformssubstantially inwardly to exert localized pressure against a region ofthe heart.

In another method of use, a pericardial edge management system (PEMS)may be used in the surgical procedure for safe introduction of theimplant 1. A PEMS includes multiple separate sheets that each have one“peel and stick” side, and may be made of Teflon. These sheets can beused to keep the opening into the pericardium open to facilitateinsertion of the device without damage to the pericardium (i.e., theinsertion tool getting hung up on the edges of the opening). Inaddition, the PEMS can be used to initially separate the heart from themesh fabric. After all of the PEMS sheets are pulled out, the jacketfabric can then engage the heart.

Referring to FIGS. 6A-6C, some embodiments of a delivery device 200 canbe used by a clinician to install the implant 100 onto a patient'sheart. As described in detail below, during a procedure to install theimplant 100, some distal portions of the delivery device 100 aretemporarily advanced within the body of the patient, while otherproximal portions of the delivery device 100 remain external to thepatient's body. The delivery device 200 used for installing the implant100 is a sterile device. In some embodiments, the delivery device 200 isa sterile single-use device. Alternatively, the delivery devices may bedesigned to be re-sterilized and reused.

In this embodiment, the implant 100 is loaded onto the delivery device200 at a distal end of the delivery device 200. A main body 210 of thedelivery device 200 is located near a proximal end of the deliverydevice 200. A barrel assembly 220 extends from the main body 210 to thedistal end of the delivery device 200. The implant 100 surrounds and iscoupled to a distal end of the barrel assembly 220. A proximal end ofthe barrel assembly 220 is attached to the main body 210. A heartstabilizer assembly 230, which may be configured to releasably anchor tothe apex of the hearth H during an implantation procedure, extends froma proximal end of the main body 210 to the distal end of the barrelassembly 220.

In some embodiments, the delivery device 200 and the implant 100 arepre-assembled and packaged together in sterile packaging. That is, thedelivery device 200 can be provided to a clinician with the implant 100pre-loaded onto the delivery device 200 and ready for sterile use. Asdescribed elsewhere herein, implants 100 of various sizes are used inorder to properly fit multiple sizes of hearts. Therefore, a hospitalthat performs procedures to install the implants 100 may keep aninventory of various sized implants 100, each of which is pre-loaded ona particular delivery device 200 and packaged in sterile packaging.After the clinician determines the size of patient's heart, theclinician can select from the hospital's inventory the implant 100 thatis sized to best fit the patient's heart. The clinician will receive asterile delivery device 200 that is pre-loaded with that selected sizeof implant 100. After the implant 100 is deployed from the deliverydevice 200, the delivery device 200 may be discarded as a single-useinstrument (for those embodiments in which the delivery device 200 ispackaged as a single-use device).

Still referring to FIGS. 6A-6C, the main body 210 of the delivery device200 may optionally include a pistol grip type handle 212 for handling bya clinician and also may include a lock release button 214 for the heartstabilizer 230. The pistol grip handle 212 provides a convenient andergonomic structure by which a clinician can grasp and maneuver thedelivery device 200. In some embodiments, the pistol grip handle 212includes a textured surface to enhance the friction between the pistolgrip handle 212 and the clinician's hand. The lock release button 214 inthis embodiment is a spring-loaded depressible button that is biased toextend outward from the main body 210. When the lock release button 214is depressed inward in relation to the main body 210, the heartstabilizer assembly 230 is unlocked and therefore able to translateaxially relative to the pistol grip type handle 212. When the lockrelease button 214 is not depressed, the lock release button 214 extendsoutward from the main body 210 and the heart stabilizer assembly 230 islocked in its axial position and therefore not able to translateaxially.

The barrel assembly 220 of the delivery device 200 may optionallyinclude a splined elongate barrel 222 for guiding the actuators 224 ofthe delivery device 200. In this embodiment, six actuators 224 areincluded around the periphery of the barrel 222. In other embodiments,fewer or more than six actuators can be included in a delivery device.The actuators 224 are each individually slidably coupled to a spline ofthe barrel 222. The actuators 224 are also each individually releasablycoupled to an epicardial management strip 250. In this embodiment, thereare a total of six epicardial management strips 250. The epicardialmanagement strips 250 extend from the actuators 224, on the externalsurface of the barrel 222, under the implant 100, and terminate wherethe implant 100 is coupled to the delivery device 200. The epicardialmanagement strips 250 provide low-friction surface area that facilitatesthe advancement of the implant 100 onto a heart. The epicardialmanagement strips 250 are not shown in FIG. 6C so that other componentsof the implant 100 and delivery device 200 are visible.

Still referring to FIGS. 6A-6C, the heart stabilizer assembly 230 caninclude a vacuum connection fitting 232, a shaft rack 234, a vacuum tube236, and a distal vacuum cup 238. Those components of the heartstabilizer assembly 230 are affixed together in the configuration asshown. That is, when the heart stabilizer assembly 230 is moved inrelation to the other parts of the delivery device 200 (while the lockrelease button 214 is depressed), the vacuum connection fitting 232,heart stabilizer shaft rack 234, vacuum tube 236, and vacuum cup 238move as a unit together in the axial direction.

In this embodiment, the vacuum connection fitting 232 is a barbedfitting. Other types of fittings can also be used, such as luerconnections, compressing fittings, threaded fittings, quick-lockfittings, and the like. A source of negative pressure (vacuum) can beconnected via flexible tubing (not shown) to the vacuum connectionfitting 232. The negative pressure will be communicated from the vacuumconnection fitting 232, through the vacuum tube 236, and to the vacuumcup 238.

The shaft rack 234 of the heart stabilizer assembly 230 is configured tobe releasably engageable with the lock release button 214. Engagementbetween the shaft rack 234 and the lock release button 214 effectuatesthe locking of the heart stabilizer assembly 230 in a selected axialposition in relation to the main body 210 and barrel assembly 220.Disengagement of the shaft rack 234 and the lock release button 214(when the lock release button 214 is depressed) unlocks the heartstabilizer assembly 230 such that the heart stabilizer assembly 230 canmove axially in relation to the main body 210 and barrel assembly 220.

In this embodiment, the shaft rack 234 includes a series of holes withwhich one or more protrusions on the shaft lock release button 214engage. When the lock release button 214 is extending outward from themain body 214 (which is the default position of the button 214), the oneor more protrusions on the lock release button 214 extend into one ormore holes on the shaft rack 234 to lock the heart stabilizer assembly230 in place. In contrast, when the lock release button 214 is depressedtowards the main body 214 (e.g., by manually pushing the button 214),the one or more protrusions on the lock release button 214 becomedisengaged from the holes on the shaft rack 234. As a result ofdepressing and maintaining the lock release button 214 in a depressedposition, the heart stabilizer assembly 230 becomes unlocked and free tomove axially in relation to the other parts of the delivery device 200.That is the case because depressing and maintaining the lock releasebutton 214 in a depressed position disengages the protrusions of thelock release button 214 from the holes of the shaft rack 234. When thelock release button 214 is no longer maintained in the depressedposition, the outward bias of the lock release button 214 causes thebutton 214 to translate to an extended position to once again lock theheart stabilizer assembly 230 in relation to the other parts of thedelivery device 200.

In one example, a comparison of FIGS. 6A and 6B illustrates how theheart stabilizer assembly 230 can translate axially when the lockrelease button 214 is pressed. For example, in FIG. 6A the heartstabilizer assembly 230 is in an axially retracted position (a proximalposition). To extend the heart stabilizer assembly 230 distally (e.g.,to the position shown in FIG. 6B), first the lock release button 214 ismanually pressed and maintained in a depressed position, and then theheart stabilizer assembly 230 can be manually slid distally in the axialdirection. In the configuration of FIG. 6B, and as will be describedfurther below, the vacuum cup 238 extends distal-most and is positionedto be the initial member of the delivery device 200 to be inserted intothe chest cavity of a patient during an implant 100 installationprocedure.

Various other design embodiments for locking and unlocking the heartstabilizers are also envisioned. Such embodiments can include the useof, but are not limited to, eccentric collars, cam mechanisms,interlocking tapers, over-center devices, set screws, and the like.

Still referring to FIGS. 6A-6C, the location of the fillable bladder 120on the implant 100, and more specifically, the relative orientation ofthe fillable bladder 120 in relation to the pistol grip handle 212 ofthe delivery device 200 can provide a number of benefits in someembodiments. For example, the implant 100 can be loaded onto thedelivery device 200 in a predetermined orientation such that thelocation of the fillable bladder 120 in relation to the pistol griphandle 212 facilitates alignment of the bladder with a targeted surfaceregion of the heart H during deployed of the implant 100 over the heatH. In such circumstances, a clinician may be able to ascertain theposition of the fillable bladder 120 based on the position of the pistolgrip handle 212. This feature can be advantageous, for example, duringan implantation procedure when the fillable bladder 120 is within thechest cavity of a patient and therefore out of the direct sight of theclinician. For example, during use, the clinician will be estimate thelocation of the fillable bladder 120 relative to the targeted surfaceregion of the heart based on the orientation of the pistol grip handle212 in the clinician's hand.

In this embodiment illustrated in FIG. 6C, when viewing on an axialsight-line in a proximal direction at the distal end of the deliverydevice 200, the fillable bladder 120 is on the left side of the deliverydevice 200 (e.g., at the “9 o'clock” position) when the pistol griphandle 212 is extending vertically downward (e.g., at the “6 o'clock”position). Stated in another way, and as shown in the side views ofFIGS. 6A and 6B, from the perspective of a clinician holding the pistolgrip handle 212 vertically downward and in front of the clinician (e.g.,see FIG. 16A), the fillable bladder 120 is located on the right side ofthe delivery device 200 (e.g., at the “3 o'clock” position relative tothe “6 o'clock” position of the handle 212). Other embodiments may usedifferent variations of orienting a fillable bladder in relation to thedelivery device. For example, in some embodiments the fillable bladdermay be located on the other side of the delivery device, on the upper orlower sides, or at any other position around the periphery of the barrelassembly 220.

Referring now to FIG. 7 (in addition to FIGS. 6A and 6B), someembodiments of the delivery device 200 include multiple epicardialmanagement strips 250 that are positioned between the barrel 222 and theimplant 100 during advancement of the implant 100 toward and over theapex of the heart H. As mentioned previously, epicardial managementstrips 250 can be used to assist with the installation of an implant 100onto the heart H. As the implant 100 is slid over the heart H, theepicardial management strips 250 can be temporarily positioned betweenthe epicardial surface of the heart and the implant 100. The epicardialmanagement strips 250 can be made of a flexible, lubricious material toprovide low-friction surface area that facilitates the slidingadvancement of the implant 100 onto the heart. In this embodiment, theepicardial management strips 250 are components of the delivery device200 and are preloaded on the delivery device 200, as is the implant 100.After the implant 100 is installed and seated in the selected position(e.g., with the hem 113 positioned in the atrial-ventricular groove ofthe heart H), the epicardial management strips 250 are removed from thechest cavity.

The epicardial management strips 250 can be made from a variety ofdifferent materials, including but not limited to,polytetrafluoroethylene (PTFE), expanded-PTFE (ePTFE),ultra-high-molecular-weight polyethylene (UHMWPE), fluorinated ethylenepropylene (FEP), perfluoroalkoxy (PFA), and the like. In someembodiments, a lubricious coating or surface treatment can be applied tothe material used to make the epicardial management strips 250. Thematerials selected to construct the epicardial management strips 250have properties such as a low coefficient of friction, biocompatibility,and resistance to absorption of liquids. The thickness of the epicardialmanagement strips 250 can be selected to provide the desired levels oflateral flexibility, column strength, and other mechanical properties.For example, in some embodiments the thickness of the epicardialmanagement strips 250 are in the range of about 0.010 inches to about0.100 inches (about 0.25 mm to about 2.54 mm).

In this embodiment, there are a total of six epicardial managementstrips 250. The epicardial management strips 250 extend from theactuators 224, over the external surface of the barrel 222, under theimplant 100, and terminate where the implant 100 is coupled to thedelivery device 200. In this embodiment, the epicardial managementstrips 250 include a proximal portion 252, a distal portion 254, and anintermediate portion 256 therebetween. The proximal portion 252 includesa first clearance hole 253 that is configured to engage with a barbedprotrusion located on the actuators 224. The distal portion 254 is awidened area that slides on the heart's surface as an implant 100 isbeing installed. A second clearance hole 255 is located at the distalportion 254. The second clearance hole 255 is configured to allow aportion of the mesh material of the implant 100 to pass therethrough,whereafter the portion of mesh material is releasably coupled with thedelivery device 200.

Referring now to FIGS. 8A-8E, the delivery device 200 is illustratedfrom multiple perspectives. In these views, the implant 100 andepicardial management strips 250 are not shown for purposes ofillustrating the barrel assembly 220 and other components distalthereto. As described previously, the delivery device 200 includes themain body 210, barrel assembly 220, and heart stabilizer assembly 230.In addition, the delivery device 200 includes multiple elongate armassemblies 240. As described further herein, the arm assemblies 240 canbe individually and selectively extended from the barrel assembly 220 toconvey the implant 100 onto a heart. Thereafter, the arm assemblies 240can be decoupled from the implant 100 and retracted from the patient'schest space (along with the epicardial management strips 250 not shownin FIGS. 8A-8E), while the implant 100 remains in a selected position onthe patient's heart H (e.g., with the hem 113 positioned in theatrial-ventricular groove of the heart H).

The arm assemblies 240 extend from the distal end of the barrel assembly220 and terminate at free ends 244. A proximal end of each arm assembly240 is coupled to an actuator 224. In this embodiment, the deliverydevice 200 includes six actuators 224 and six corresponding armassemblies 240. Other embodiments may include more than six or fewerthan six actuators and arm assemblies. In this embodiment, each actuator224 is coupled to one and only one arm assembly 240, and each armassembly 240 is coupled to one and only one actuator 224. However, insome embodiments, more than one arm assembly may be coupled to oneactuator. As described further herein, the distal free ends 244 of thearm assemblies 240 are configured to releasably couple with the meshmaterial of an implant (refer, for example, to FIG. 6C).

Referring to FIGS. 8F and 8G, the elongate arm assemblies 240 arelaterally flexible and axially extendable members. That is, each of thearm assemblies 240 can elastically bend laterally and translate axiallyin the depicted embodiment. Such properties can be useful for conveyingan implant through a relatively small chest opening, into thepericardial cavity of a patient, and then onto the ventricles of thepatient's heart H in an atraumatic manner.

In this embodiment of the delivery device 200, the elongate armassemblies 240 can be manually adjusted between a retracted position(depicted in FIG. 8F) and an extended position (depicted in FIG. 8G). Inthe extended position, the elongate arm assemblies 240 project distallyfrom the distal end 221 of the barrel assembly 220 to a greater extentthan when the arm assemblies 240 are in the retracted position. Thisability of the arm assemblies 240 to extend distally is useful for thepurpose of conveying an implant onto the heart of a patient. That is,while the distal end 221 of the barrel assembly 220 remains outside ofthe chest cavity, the arm assemblies 240 can be extended through a chestincision, and then extended into the chest cavity of the patient. Thearm assemblies 240 can be extended further to project around theventricles of the patient's heart to place the implant 100 onto theheart H (e.g., refer to FIGS. 1B, 4A, and 4B). The flexibility of thearm assemblies 240 can be useful because the arm assemblies sustainflexure during the minimally invasive implantation procedure. Forexample, after passing through the chest incision, at least some of thearm assemblies 240 thereafter bend to follow the contours of the heartH. Because the arm assemblies 240 are laterally compliant, the armassemblies 240 can enter the chest through a small incision (e.g., amini-thoracotomy) and elastically flex within the chest cavity to conveyan implant 100 onto the patient's heart H.

In the depicted embodiment, the arm assemblies 240 can be extended andretracted by moving the arm actuators 224. That is the case, because theproximal ends of the arm assemblies 240 are coupled to the actuators224. In order to axially move an arm assembly 240, the correspondingactuator 224 can be slid along the splined elongate barrel 222. Forexample, because the actuators 224 are located near the proximal end ofthe splined elongate barrel 222 in FIG. 8F, the arm assemblies 240 arein retracted positions. In contrast, because the actuators 224 arelocated near the distal end of the splined elongate barrel 222 in FIG.8G, the arm assemblies 240 are in extended positions.

Referring to FIGS. 9A-9C, the arm actuators 224, and the correspondingarm assemblies 240 coupled thereto, can be individually axiallytranslated along the axis of the splined elongate barrel 222. Forexample, arm actuator 214 a has been slid to a location that is distalof the other arm actuators 224. The corresponding arm assembly 240 a istherefore extended further distally from the distal end 221 of thebarrel 222 than the other arm assemblies 240. In some embodiments,multiple arm actuators 224 and arm assemblies 240 can be movedconcurrently using a mechanical member that simultaneously translatesthe multiple arm actuators 224.

In this embodiment of the delivery device 200, the actuators 224 and thearm assemblies 240 are each individually slidably coupled with a spline223 of the barrel 222. Each arm assembly 240 can be at least partiallydisposed in a corresponding spline 223 of the splined elongate barrel222. For example, arm assembly 240 a is partially disposed in spline 223a. The open space defined by the splines 223 is larger than the outerprofile of the portion of the arm assemblies 240 disposed therein. Assuch, the arm assemblies 240 are free to slide axially within thesplines 223. The arm actuators 224 are also partially disposed in orengaged with a particular spline 223. For example, arm actuator 224 a isengaged with spline 223 a. The arm actuators 224 include shuttleportions that have shapes that are complementary to the shape of thesplines 223. As a result, the arm actuators 224 are coupled to, and areslidable in relation to, the splines 223.

Referring to FIGS. 9A-9C and FIG. 10, the main body 210 can include anactuator lock ring 216. The actuator lock ring 216 can be operated toretain the arm actuators 224 at the arm actuator's 224 proximal-mostposition on the barrel 222. This feature can be useful for purposes ofrestraining the arm assemblies 240 from inadvertently extending.

The actuator lock ring 216 can be rotatably coupled to the main body210. That is, in this embodiment the actuator lock ring 216 is coupledto, and is free to be manually rotated in relation to the main body 210.In addition, the actuator lock ring 216 can be manually rotated inrelation to the barrel 222 and the arm actuators 224 slidably coupledthereto.

The actuator lock ring 216 includes a rotatable lock knob 218 that canbe manually rotated to lock or unlock the actuators 224 to the main body210. The actuator lock ring 216 also includes six slots 217 (shown inFIG. 10) that are disposed about the inner diameter of the ring 216. Theslots 217 are configured to be selectively alignable with the splines223 of the barrel 222. The slots 217 are also configured to receiveactuator tabs 225 (refer to FIG. 9C) that are located on the proximalends of the arm actuators 224. When the slots 217 of the actuator lockring 216 are in alignment with the splines 223, and the arm actuators224 are slid to the distal-most end of travel on the barrel 222, thenthe tabs 225 pass through the slots 217 and reside proximally to theslots 217. Thereafter, the actuator lock ring 216 can be rotated via thelock knob 218 such that the slots 217 are no longer aligned with thesplines 223, thereby locking the arm actuators 224 to the main body 210.For example, in FIG. 9A the actuator lock ring 216 is in a rotaryposition where the slots 217 are not aligned with the splines 223.Therefore, the arm actuators 224, other than actuator 224 a, are lockedto the main body 210. In contrast, in FIG. 9B the actuator lock ring 216is in a rotary position where the slots 217 are aligned with the splines223. For instance, slot 217 a is visibly aligned with slot 223 a.Therefore, all of the arm actuators 224 are not locked to the main body210. In result, the arm actuators 224 can be slid in relation to themain body 210 and splined barrel 222.

In the cross-sectional view of FIG. 9B, it can be seen that each of thearm assemblies 240 include an elongate hollow outer jacket 241. Thehollow outer jacket 241 defines an open interior space, or lumen, thatcan contain another member, such as a core member 242 described inconnection with FIGS. 11A-11B.

Referring now to FIGS. 11A and 11B, in this embodiment each of the armassemblies 240 include the hollow outer jacket 241, the core member 242,and an arm cap 243. The core member 242 is slidably disposed within thelumen of the hollow outer jacket 241. The arm cap 243 is affixed to thedistal end of the hollow outer jacket 241. Therefore, the core member242 can also be slid in relation to the arm cap 243. In otherembodiments, other configurations of the arm assemblies 240 can be usedwhile providing similar functionality.

As described previously, arm actuators 224 are coupled to correspondingarm assemblies 240. For example, when an arm actuator 224 is axiallytranslated in relation to the splined barrel 222, a corresponding armassembly 240 is extended or retracted from the distal end 221 of thebarrel 222. As each arm assembly 240 is extended or retracted, thehollow outer jacket 241, core member 242, and arm cap 243 of the armassembly 240 can be extended or retracted in equal distances, and inunison.

The arm actuators 224 are coupled to arm assemblies 240 in a secondmanner that allows each actuator 224 to move the core members 242 of thecorresponding arm assembly 240 relative to the hollow outer jacket 241and arm cap 243. In particular, the arm actuators 224 are coupled to thecore members 242 such that pivoting an actuator lever 226 of an armactuator 224 can advance or retract a core member 242 of an arm assembly240 in relation to the outer jacket 241 and arm end 243 of the armassembly 240. The pivotable actuator lever 226 of an actuator 224controls the core member 242 of the arm assembly 240 to which theactuator 224 is coupled.

The pivotable actuator lever 226 is shown pivoted away from the barrel222 in FIG. 11A, such that the longitudinal axis of the pivotableactuator lever 226 is roughly perpendicular to the axis of the barrel222. In contrast, the pivotable actuator lever 226 is shown pivotedtoward the barrel 222 in FIG. 11B, such that the longitudinal axis ofthe pivotable actuator lever 226 is roughly parallel with the axis ofthe barrel 222. Such pivoting of the actuator lever 226 controls theaxial position of the core member 242 in relation to the hollow outerjacket 241 and the arm cap 243. For example, in FIG. 11A no core memberis visible within the window of the arm cap 243. In contrast, in FIG.11B, the core member 242 is visible within the window of the arm cap243. This comparison illustrates that, in this embodiment, when anactuator lever 226 is pivoted away from the barrel 222, a core member242 is retracted in the axial direction. Conversely, when an actuatorlever 226 is pivoted toward the barrel 222, a core member 242 isadvanced distally in the axial direction.

This second manner by which arm actuators 224 are coupled to armassemblies 240 can be operated independently of axially translating anarm actuator 224 in relation to the splined barrel 222 to extend orretract a corresponding arm assembly 240. So, for example, at any axialposition of an arm actuator 224, the actuator lever 226 can be pivotedto advance or retract the core member 242. Further, the two movements(axial translation of an arm actuator 224 and pivoting of the actuatorlever 226) can be performed contemporaneously.

The advancing and retracting of the core members 242 within the windowsof the arm ends 243 can be advantageously used for releasably couplingan implant to the delivery device 200. In some embodiments, a portion ofthe mesh body 110 of the implant 100 can be crimped and contained withina window of an arm end 243 (refer, for example, to FIG. 6C) when thecore member 242 is in the advanced position. When it is desired torelease the implant 100 from the delivery device 200, the actuatorlevers 226 can be pivoted to retract the core members 242, and the meshmaterial will then no longer be crimped within the windows of the armends 243, and the implant 100 can then be separated from the deliverydevice 200. Thereafter, the arm assemblies 240 can be retracted from thepatient's chest space (along with the epicardial management strips 250not shown in FIGS. 8A-11B), while the implant 100 remains in a selectedposition on the patient's heart H (e.g., with the hem 113 positioned inthe atrial-ventricular groove of the heart H).

Referring now to FIGS. 12A-12C, some embodiments described hereininclude a method 300 for installing an implant in a patient to treat aheart condition. In some implementations, such heart conditions caninclude, but are not limited to, functional mitral regurgitation,tricuspid valve regurgitation, and congestive heart failure. In someembodiments of the method 300, a cardiac implant (including but notlimited to the implant 100 described above) is implanted to surround anexterior portion of the patient's heart. The implant employed in themethod 300 may include one or more fillable bladders. The fillablebladders can be configured for installation at a selected position onthe targeted epicardial region of the heart (for example, on a posteriorwall of the heart adjacent the mitral valve) so that the fillablebladder will exert a localized pressure to induce the remodeling of aportion of the heart when the fillable bladder is inflated. In theexample of positioning a fillable bladder on a posterior wall of theheart adjacent the mitral valve, the fillable bladder provides localizedpressure that in turn is applied to a posterior portion of the mitralvalve annulus (refer to FIG. 1B), thus bringing the leaflets of thevalve into closer proximity with one another and treating a mitral valveregurgitation problem.

Referring to FIG. 12A, in some implementations of the method 300, step302 includes identifying the apex of a patient's heart. This step mayinvolve the use of one or more imagining modalities. For example, insome embodiments, radiographic and/or transthoracic echocardiographicinformation is attained to assist in the identification of the apex ofthe heart.

At step 304 in some implementations of the method 300, a location for anincision to access the patient's heart is selected, and then an incisionthrough the patient's skin is made. In some embodiments, the selectedlocation of the incision will allow access to the apex of the heart inalignment with the long axis of the heart. Such an incision can allow animplant delivery device to be inserted into the patient's chest cavitysubstantially coaxially with the heart (e.g., as in step 326).Therefore, the location for the incision can be made at least partlybased on the location of the apex of the patient's heart as ascertainedin step 302. In some implementations, an intercostal incision locationis selected. For example, in particular implementations the fifthintercostal space may be selected. However, the selected incisionlocation can be patient-specific. In some implementations, the incisioncomprises a mini-thoracotomy heart access procedure. In some embodimentsof method 300, a minimum size of incision is recommended. For example,for the delivery device 200 described above, a minimum incision of 7 cmis recommended, although that is optional in some implementations.

At step 306 in some implementations of the method 300, surgicalretraction is performed to create and maintain a surgical passagewaythrough the patient's incised skin. In some implementations, alow-profile retractor is used. In some embodiments of method 300, aseparation distance of the retractor blades is recommended. For example,when the delivery device 200 described above will be used, the retractorblades should be separated by at least about 4 cm.

At step 308 in some implementations of the method 300, the pericardiumis incised and retracted to provide access to the heart's apex. In someembodiments, the selected location of the incision will allow access tothe apex of the heart in alignment with the long axis of the heart. Insome embodiments of method 300, a minimum size of incision isrecommended. For example, for the delivery device 200 described above, aminimum incision of 7 cm is recommended, although that is optional. Theedges of the pericardium can be retracted by suturing the edges to thesurrounding tissues.

At step 310 in some implementations of the method 300, an inspection ismade for pericardial adhesions. Pericardial adhesions are an attachmentof the pericardium to the heart muscle. In some implementations,contrast agent solution may be injected into the pericardium to enhancevisualization of pericardial adhesions. If pericardial adhesions thatmay impede complete circumferential access to the heart are identified,the clinician may abandon the method 300 at this point.

At step 312 in some implementations of the method 300, multiplepericardial edge management strips (PEMS) are installed. The PEMS can beused to cover exposed edges of the pericardium, and to create a cleartunnel for access (e.g., by delivery tool 200) to the apex of the heart.In some implementations, four to six PEMS are installed. In otherimplementations, fewer than four or more than six PEMS may be installed.The PEMS are sterile devices.

One example embodiment of PEMS is illustrated in FIGS. 13A and 13 B. Asshown, in some embodiments the PEMS 400 includes a masking member 410, amalleable member 420, and an adhesive member 430. The malleable member420 and the adhesive member 430 can be attached to the masking member410. In some embodiments, the malleable member 420 is disposed betweenmultiple layers of masking member 410 material. The masking member 410can be a flexible biocompatible film such as Teflon, polyester,polyurethane, and the like. The malleable member 420 can be a thin gaugemetallic material, such as a stainless steel, titanium, and the like, oralloys thereof. The adhesive member 430 can be a pressure-sensitivebiocompatible material such as a medical-grade acrylic adhesive, orother medical-grade adhesives. The adhesive member 430 can comprise anadhesive pad or be coated onto the masking member 410. The adhesivemember 430 is covered by a liner 432 that is removed when the PEMS 400are put into use.

One non-limiting example of step 312 (using the PEMS 400) is illustratedin FIG. 13C. A retractor device 440 for spreading open an incision inthe chest 460 of a patient depicted. Four PEMS 400 are partiallyinserted in the chest cavity of a patient to create an access tunnel450. The end opposite the adhesive member 430 is inserted through theincision and into the pericardial space. Care is used to ensure that theinserted end of the PEMS 400 is within the pericardial space and is notinserted too deep into the incision such that the PEMS 400 willinterfere or damage other cardiac structures. The exposed portion of thePEMS 400 is bent back (thereby deforming the malleable member 420) sothat the PEMS 400 is in contact with the sterile surgical drape aroundthe incision site. The adhesive liner 432 is removed. The adhesivemember 430 of the PEMS 400 is adhered to the sterile surgical draping onthe chest 460 of the patient. This process is repeated with additionalPEMS 400 until the all edges of the pericardium are covered by PEMS 400.

Referring again to FIG. 12A, in some implementations of the method 300,step 314 includes identifying the atrial-ventricular groove. In someimplementations, the atrial-ventricular groove is identified usingfluoroscopy. Multiple fluoroscopic images from various angles may needto be used to ascertain the location of the atrial-ventricular groove.In some implementations, the injection of a contrast solution into thepericardial space (e.g., between the pericardium and the epicardium) mayenhance the visibility of the atrial-ventricular groove. The boundariesof other cardiac structures may also be determined in this step.

In some implementations of the method 300, the optional step 316includes intra-operatively measuring the ventricular perimeter of thepatient's heart. In some instances, the measurement may have alreadybeen performed pre-operatively using imaging modalities such as a CATscan, MRI, ultrasound, and the like. In such instances, step 316 may beoptional to perform.

An example intra-operative sizing device 500 for performing step 316 isdepicted in FIGS. 14A-14C. In some embodiments, the sizing device 500includes a main body 510, a vacuum assembly 520, sizing arms 530, andsizing cords 540. The vacuum assembly 520 is slidable in relation to themain body 510. The arms 530 are fixed to the main body 510. The cords540 (in the embodiment depicted there are three cords) are attached atone end to the end cap 532 of one of the arms 530, and at another end toa sizing positioner 512 in the main body 510.

In some embodiments, the main body 510 includes a casing 511, sizingpositioners 512, a sizing indicator 513, and a sizing scale 514. Thesizing positioners 512, which are linked to the sizing indicator 513,are slidable in relation to the casing 511. The sizing scale 514 isaffixed to the casing. As the sizing positioners 512 are axiallytranslated, the sizing indicator 513 moves in unison. The clinician canascertain the measurement by viewing the sizing indicator 513 inrelation to the sizing scale 514.

The sizing device 500 also includes a vacuum assembly 520. In someembodiments, the vacuum assembly 520 can include a vacuum fitting 521, aknob 522, a vacuum shaft 523, and a vacuum stabilizer cup 524. Theaforementioned components of the vacuum assembly 520 are affixed to eachother and axially translate in relation to the main body 510 as a unit.The vacuum fitting 52 is in fluid communication with the vacuum shaft523, which is in fluid communication with the vacuum stabilizer cup 524.Hence, when a source of negative pressure is attached to the vacuumfitting, negative pressure is communicated to the vacuum shaft 523 andvacuum stabilizer cup 524.

In some embodiments, the sizing device 500 also includes multiple sizingarms 530. In the depicted embodiment, three arms 530 are included thatare disposed at about 120 degrees apart from each other. In otherembodiments, fewer or more arms are included. One end of the arms areaffixed to the main body 510, while the other ends of the arms 530 arefree ends having end caps 532. The arms 530 are laterally elasticallyflexible. That is, the arms 530 can radially deflect away from thevacuum shaft 523 while having one end affixed to the main body 510. Assuch, in some embodiments the arms 530 are made from a polymericmaterial such as Acrylonitrile Butadiene Styrene (ABS), PolyvinylChloride (PVC), Cellulose Acetate Butyrate (CAB), Polyethylene (PE),High Density Polyethylene (HDPE), Low Density Polyethylene (LDPE orLLDPE), Polypropylene (PP), Polymethylpentene (PMP), Polycarbonate (PC),Polyphenelyne Ether (PPE), Polyamide (PA or Nylon), and the like. Theend caps 532 include clearance holes through which a sizing cord 540freely passes.

The sizing device 500 also includes sizing cords 540. In the embodimentdepicted, three sizing cords 540 are included. In other embodiments,fewer or more cords are included. The cords can be comprised of abiocompatible material such as, but not limited to, PTFE, ePTFE,polypropylene, polyglycolide, nylon, and other like materials. Each cord540 have two ends. A first end of the cords 540 is attached to thesizing positioners 512, and a second end of the cords are individuallyattached to an end cap 532. Therebetween, the cords 540 individuallypass through a clearance hole in an end cap 532.

In one embodiment, the process for using the sizing device 500 is asfollows. A source of negative pressure is connected to the vacuumfitting 521. The vacuum assembly 520 is fully extended in relation tothe main body 510. The vacuum stabilizer cup 524 is inserted through thechest incision and placed in contact with the apex of the heart. Themain body 510, and sizing arms 530 affixed thereto, are carefullyadvanced into the pericardial cavity so that the arms 530 and the cords540 surround the heart. An imaging system, such as a fluoroscope, can beused to provide visualization of the advancement. As the arms and cords540 are advanced, the sizing positioners 512 may move distally inrelation to the main body 510 as the cords 540 require additional lengthto surround the heart. The advancement is stopped when the sizer cords540 are around the largest perimeter of the heart. The sizer positioners512 are then carefully pulled back (manually) to remove any slack in thecords 540. Using fluoroscopy, the clinician confirms that the cords 540are not over-tightened (e.g., that the heart is not indented by thecords 540). The clinician then observes the relative position of thesizing indicator 513 to the sizing scale 514. The clinician can therebyascertain the size of the largest perimeter of the heart, and thereafterremove the sizing device 500.

Referring again to FIG. 12A, in some implementations of the method 300,step 318 can include selecting an implant, which may be includeselecting the implant based at least in part on the size of thepatient's heart as determined previously. In some embodiments, theimplant will be pre-loaded on a delivery device in sterile packaging, aspreviously described herein. The epicardial management strips may alsobe pre-loaded on the delivery device.

At step 320 in some implementations of the method 300, a source ofnegative pressure is connected to the delivery device. In the context ofthe example delivery device 200, the negative pressure is attached tovacuum connection fitting 232. The negative pressure will becommunicated to the vacuum cup 238 of the heart stabilizer 230.

At step 322 in some implementations of the method 300, the vacuumstabilizer is fully extended. In the context of the example deliverydevice 200, the heart stabilizer 230 is fully extended in relation tothe main body 210.

At step 324 in some implementations of the method 300, the vacuumstabilizer is inserted through the incision and into pericardial tunnel.An example of this step is illustrated in FIG. 15. There the vacuum cup238 of example delivery device 200 is being inserted into thepericardial tunnel 450. The implant 100 is coupled to the deliverydevice 200.

Referring now to FIG. 12B, at step 326 the fillable bladder isrotationally aligned to a target location on the heart, in accordancewith some implementations of the method 300. For example, in someinstances the target location may be on the posterior lateral surface ofthe heart where the fillable bladder will be able to deflect the “P2”portion of the posterior leaflet of the mitral valve to treat FMR. Othertarget locations may be selected in other instances depending on thecondition to be treated using method 300. In this step, the relativepositioning between features of the delivery device and the fillablebladder can be used advantageously. In the context of the exampledelivery device 200, as explained above, the relative orientation of thefillable bladder 120 in relation to the pistol grip handle 212 of thedelivery device 200 can have a predetermined orientation such that aclinician may be able to ascertain the position of the fillable bladder120 based on the conveniently held position of the pistol grip handle212 over the patient's body. Based on the known orientation, theclinician will be estimate the location of the fillable bladder 120relative to the targeted surface region of the heart based on theorientation of the pistol grip handle 212 in the clinician's hand.

At step 328 in some implementations of the method 300, the vacuumstabilizer is applied to the apex of the patient's heart. The negativepressure at the delivery device is active at this step. Therefore, thevacuum stabilizer becomes attached to the apex using vacuum. The apex ofthe heart is thereby stabilized in relation to the delivery device.

At step 330, the arm actuators can be unlocked. In the context of theexample delivery device 200, the clinician rotates the actuator lockring 216, as previously described. Thereafter, all of the arm actuators224 are not locked to the main body 210, and the arm actuators 224 canbe slid in relation to the main body 210 and splined barrel 222 of thedelivery device 200.

At optional step 332 in some implementations of the method 300, theheart can be temporarily elongated. The clinician can perform this stepby exerting a slight directed pull on the delivery device in a proximaldirection. Doing so may elongate the shape of the heart at the heart'sapex and ease the initial deployment of the delivery tool's arms overthe heart.

At step 334, the arms of the delivery device are incrementally extendedwhile using imaging to view the position of the arms relative to theheart. FIGS. 16A-16C illustrate one non-limiting example of the step334, in accordance with some implementations of the method 300. In FIG.16A a clinician is shown operating a delivery device 200. The clinicianis extending the arms 240 of the delivery device, incrementally andindividually, by sliding the actuators 224 distally. Contemporaneously,the clinician is observing the video screen of an imaging system 600(refer to FIG. 16B) whereby the clinician can view the positions of thearms 240 in relation to the heart H. In some implementations, theradiopaque markers of the implant 100 (described above) may also aid inthe contemporaneous visualization process and to verify the positioningof the hem 113 and the bladder 120 relative to particular landmarks ofthe heart H. FIG. 16C illustrates an implant 100 that is coupled to arms240 as the arms are being extended so as to position the implant 100around the ventricles of the heart H. The arms 240 are advancedcarefully, and in many circumstances, no single arm 240 is greatlyadvanced further than the others. For example, in some implementationsit is recommended that no single arm 240 be positioned more than about 2cm beyond any other arm 240. In some implementations, it may beadvantageous to modulate the extension distance of the vacuum stabilizerin relation to the rest of the delivery device so as to achieve adesirable balance between flexibility and column strength of the armsduring this step.

At step 336, the arms are further advanced to position the leading hemof the implant in the atrial-ventricular groove of the heart. Thispositioning of the implant in the atrial-ventricular groove is depictedin FIG. 1B, for example. As previously described herein, radiopaquemarkers may be mounted on the implant to assist with the contemporaneousvisualization process and to verify the positioning of the hem 113 andthe bladder 120 relative to particular landmarks of the heart H. In thecontext of the example delivery device 200, one or more radiopaquemarkers 115 located on the hem 113 and one or more radiopaque markers125 of the bladder 120 can be used as reference points in conjunctionwith an imaging system.

At step 338, the delivery device is decoupled from the implant. In thecontext of the example delivery device 200, pivoting an actuator lever226 of an arm actuator 224 can retract a core member 242 of an armassembly 240 in relation to the outer jacket 241 and arm end 243 of thearm assembly 240 to decouple the arm assembly 240 from the implant 100.This process can be repeated for every arm assembly 240 to fullydecouple the implant 100 from the delivery device 200.

At step 340 the arms of the delivery device can be retracted. Forinstance, using the delivery device 200 as an example, the arm actuators224 can be slid proximally to withdraw each arm assembly while leavingthe implant 100 on the heart H. The epicardial management strips 250 arealso retracted along with the arms 240.

At step 342, the delivery device is withdrawn from the patient. Thenegative pressure source is discontinued, and then the entire deliverydevice is withdrawn. One non-limiting example of this step isillustrated in FIG. 17.

Referring again to FIG. 12B, at step 344 the fillable bladder(s) areinflated while patient parameters are monitored. Sterile saline solutionor other types of inflation fluids may be used to inflate fillablebladders. For example, the inflation fluid can be dispensed from asyringe device or other inflation delivery device that is temporarilycoupled to the proximal end opening of the tube. When the conditionbeing treated is valvular regurgitation, the valve may be monitoredusing, for example, transesophegeal echocardiography or other liketechniques, while the inflation is taking place. Such contemporaneousmonitoring may assist the clinician to determine the volume of inflationfluid to administer into the fillable bladder(s). This step is alsoillustrated in FIG. 17.

Referring again to FIG. 12B, at step 346, the inflation tube of thefillable bladder is sealed. For example, one or more ligation clips maybe applied to the inflation tube to seal the tube (refer, for example,to FIGS. 1A and 1B).

Referring now to FIG. 12C, in some implementations of the method 300,step 348 may include flushing the pericardial cavity. For example,sterile saline solution can be injected and subsequently aspirated. Thisstep can be performed to remove contrast agent substances that may havebeen injected earlier in the procedure. The injection and aspiration ofthe solution can be repeated multiple times, as desired, to flush thepericardial cavity.

At step 350, the pericardial edge management strips are removed. Theremoval can be performed by reversing the steps of the implementationprocedure.

At step 352, excess mesh material of the implant is trimmed. This step352, like all other steps in some implementations of the method 300, maybe performed while the heart is beating. In such circumstances, theclinician can carefully gather the trailing end material of the implantin the area of the chest opening. Using a scissors or other cuttingdevice, the clinician can trim the excess material. Care is taken toensure a sufficient amount remains with the implant to close the implantaround the apex of the heart. One non-limiting example of this step isillustrated in FIG. 18.

Referring again to FIG. 12C, at step 354 the trailing end of the implantis closed around the apex of the heart. This can be performed bysuturing the trailing end portion and cinching the material togetherlike a purse string. The inflation tube remains extending through thecinched trailing end portion. One non-limiting example of thisconfiguration is illustrated in FIG. 1B.

Referring again to FIG. 12C, at step 356 the pericardium is looselyclosed. This step can be performed by installing a few sutures (e.g.,two or three) to close the pericardium. Having a loose closure willfacilitate drainage of fluids form the pericardium, as is common after aprocedure such as this. The inflation tube remains extending through theloosely closed pericardium.

At step 358, the end of the inflation tube is aligned in an intercostalspace and the chest incision is closed. Aligning the end of theinflation tube in the intercostal space may allow future access to theinflation tube via a simple cut-down procedure through the skin adjacentto the intercostal space between the ribs (e.g., the fifth intercostalspace in some implementations). Future inflation or deflation of thefillable bladder may thereby be performed with a minimally invasiveaccess to an intercostal space under the side without extensive surgeryto access the pericardium or epicardium.

A number of embodiments of the invention have been described.Nevertheless, it will be understood that various modifications may bemade without departing from the scope of the invention. Accordingly,other embodiments are within the scope of the following claims.

What is claimed is:
 1. A delivery system for delivering an implantablecardiac device, the delivery system comprising: an elongate barrel; aplurality of elongate members configured to extend along a length of theelongate barrel and extend distally from the elongate barrel, and beingadvanceable distally with respect to the elongate barrel, each of theelongate members comprising a distal end for attachment to a cardiacimplant configured to be implanted around an exterior of a heart, acontrol mechanism configured to extend and retract the plurality ofelongate members relative to the elongate barrel; and a handle assemblycomprising a pistol grip configured to be held by a first hand of anoperator while the operator uses a second hand to operate the controlmechanism for the extension and retraction of the plurality of elongatemembers.